### Final Report on Formaldehyde Levels

in FEMA

- Supplied Travel Tr ailers , Park Models, and Mobile Homes

From the Centers for Disease Control and Prevention

July 2 , 2008

Amended December 15 th 

### , 2010Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers i Table of Contents

Executive Summary

................................ ................................ ................................ ....................... iii

Background

................................ ................................ ................................ ................................ ...... 1

CDC Testing of Occupied Trailers

................................ ................................ .............................. 1

Formaldehyde Exposure in Residential Indoor Air

................................ ................................ ..... 3

Health Effects

................................ ................................ ................................ ............................... 4

Regulations and Standards of Formaldehyde Levels

................................ ................................ ... 5

Objectives

................................ ................................ ................................ ................................ ........ 5

Methods

................................ ................................ ................................ ................................ ............ 5

Study Personnel..........................................

....................................................... 6

Trailer Selection

................................ ................................ ................................ ........................... 6

Eligibility Criteria

................................ ................................ ................................ ........................ 7

Informed Assent and Consent and Human Subjects Protection

................................ .................. 7

Variables

................................ ................................ ................................ ................................ ...... 7

Exposure Assessment Questionnaire

................................ ................................ ........................... 7

Environmental Walk

- Through Survey

................................ ................................ ......................... 8

Formaldehyde Sample Collection

................................ ................................ ................................ 8

Temperature and Relative Humidity Sample Collection

................................ ............................. 8

Sample Collection Data Sheet

................................ ................................ ................................ ..... 8

Data Collection, Entry, Editing, and Management

................................ ................................ ...... 8

Statistical analysis

................................ ................................ ................................ ........................ 9

Results

................................ ................................ ................................ ................................ .............. 9

Participation Rates

................................ ................................ ................................ ....................... 9

Overall R ange and V ariability of F ormaldehyde L evels

................................ ........................... 10

Occupant Activities

................................ ................................ ................................ .................... 10

Trailer Characteristics

................................ ................................ ................................ ................ 10

Walk

- Through Survey

................................ ................................ ................................ ............... 10

Multivariate Analysis

................................ ................................ ................................ ................. 10

Discussion

................................ ................................ ................................ ................................ ...... 11

Limitations

................................ ................................ ................................ ................................ ..... 12

Conclusions

................................ ................................ ................................ ................................ .... 13

Recommendations :
Recommendations for Public Health, Emer gency Response, and Housing Officials

........ ... 13

Recommendations for Residents Awaiting Relocation.............................................. 14

Further CDC Action......................................................................................14

References .....................................................................................................15Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers ii Figure 1

. ............................................................ ............................................18

Figure 2

. ........................................................................................................19

Figure 3

. ........................................................................................................20

Figure 4

. ........................................................................................................21

Table 1..

........................................................................................................ 2 2

Table 2.........................................................................................................23

Table 3.........................................................................................................24

Table 4.........................................................................................................25

Table 5..........................................................................................................28

Table 6.........................................................................................................30

Table 7.........................................................................................................30

Table 8............................................................... ..........................................31

Table 9.........................................................................................................32

Appendix A. Protocol For T railer Selection and Recruitment

................................ ................ 33

Appendix B. Phone Log for Participant Recruitment

................................ ............................. 35

Appendix C. Obtaining Assent

................................ ................................ ................................ 39

Appendix D. Informed Consent for Participation

................................ ................................ ... 40

Appendix E. Exposure Questionnaire and Walk

- Through Survey

................................ ......... 43

Appendix F. Environmental Sampling Protocol

................................ ................................ ..... 49

Appendix G. Sample Data sheet for Formalde hyde, Temperature, and Relative Humidity Data Collection

................................ ................................ ................ 54Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers iii 

### Final Report on Formaldehyde Levels

in F EMA

- Supplied Travel Trailers , Park Models, and Mobile Homes

From the Centers for Disease Control and Prevention July 2 , 2008

EXECUTIVE SUMMARY

In December 2007 and January 2008, the Centers for Disease Control and Prevention (CDC) measured formaldehyde levels in a stratified random sample of 519 FEMA

supplied occupied travel trailers, park models, and mobile homes (i.e., “trailers”) . At the time of the study, sampled trailer s were in use as temporary shelter for Louisiana and Mississippi residents displa ced by h urricanes Katrina and Rita. The study aimed to determine formaldehyde levels in occupied trailers, determine trailer characteristics that could affect formaldehyde levels , and provide information to assist FEMA in deciding

whether to relocate resid ents from FEMA

- supplied trailers in the Gulf Coast area. This study assessed only current formaldehyde levels in the occupied trailers; it was not a health effects study.

To evaluate levels of formaldehyde, investigators conducted a 1

- hour continuous indo or air sample and sample measurements of indoor temperature and relative humidity. To determine factors that could affect formaldehyde levels, investigators administered a short questionnaire to adult residents about occupant demographics and trailer

chara cteristics. To observe the exterior and interior of the trailer, investigators conducted

a walk

- through survey.

In many of the trailers tested, formaldehyde levels were higher than typical U.S. indoor

levels . The geometric mean level of formaldehyde in sa mpled trailer s was 77 ppb (range:

3

– 590 ppb). Formaldehyde levels varied by trailer type, but all types tested had some

levels ≥ 100 ppb , the level at which health effects have been described in sensitive

persons

.

In this study, travel trailers had significantly higher average formaldehyde levels than did park models and mobile homes. A higher proportion of t ravel trailers than p ark models

and mobile homes also had formaldehyde levels ≥ 100 ppb and ≥ 300 ppb. In multivariate analysis

, factors such as temperature ; relative humidity ; trailer type and brand ; opened

windows , doors, and scuttles; and presence of mold ( ≥ 1 ft 2 ) were sig nificantly associated with formaldehyde levels.

Because f ormaldehyde levels tend to be higher in newly constructed trailers and during

warmer weather

, levels measured in this study are likely to underrepresent long

- term

exposures ; many of these trailers are approximately 2 years old

, and the study was conducted during the winter

. In addition, t he study did not evaluate any specific patterns of use with respect to specific types of trailers

.

O n the basis of the data reported here and in previous scientifi c reports and publications

about adverse health effects associated with exposure to elevated formaldehyde levels,Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers iv CDC recommend ed that FEMA relocate Gulf Coast residents displaced by h urricanes

Katrina and Rita and still liv ing in trailers

. Relocation pri ority should be given to occupants suffering symptoms potentially attributable to formaldehyde exposure and to vulnerable populations

, such as children, elderly persons , and persons with chronic respiratory illnesses.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 1 BACKGROUND

On August 28 and 29, 2005, Hurricane Katrina

— a Category 4 storm

— made landfall on the U.S. Gulf Coast between New Orleans, L ouisiana (LA)

, and Mobile, A labama

. On September 24,
2008, Hurricane Rita

— a Category 3 storm

— made landfall along the Texas

- Louisiana border, Many families evac uated from the U.S. Gulf Coast region returned later to find their homes severely damaged.

Starting in October 2005, the Federal Emergency Management Agency (FEMA) provided temporary housing along the Gulf Coast by supplying approximately 100,000 trailers (see box)

. In LA, more than 60% of trailers provided to residents were on private property. In Mississippi (MS), more than 78% of trailers were on private property. The remaining trailers in both states

were in FEMA

- designated trailer parks.

CDC Testing of Occupied Trailers From December 21, 2007, to January 23, 2008, the Centers for Disease Control and Prevention (CDC) assessed levels of formaldehyde in indoor air of a random sample of occupied FEMA

supplied trailers. Formaldehyde test ing was one of seve ral actions CDC initiated in response to a July 13, 2007, request from FEMA to investigate concerns about formaldehyde in occupied FEMA trailers in LA and MS. This report details only the testing of occupied trailers for formaldehyde levels ; it was not a h ealth effects study.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 2 Definitions for Traile rs Used by FEMA for Gulf Coast Residents Displaced by Hurricanes Katrina and Rita

**•** Mobile homes are manufactured homes wider than 8 feet or longer than 40 feet (for an area >320

ft 2 ). They are built on permanent chassis; contain plumbing, heating, air

- cond itioning, and electrical systems; and are designed for use as permanent dwellings. Mobile homes are defined and regulated by the U.S. Department of Housing and Urban Development (HUD).

**•** Park models are manufactured homes of 320

– 400 ft 2 administratively exem pted from HUD formaldehyde standards. Park models may be regulated by transportation authorities and by manufacturer acceptance of a voluntary American National Standards Institute standard applying

to their construction.

**•** Travel trailers are wheel

- mounted trailers designed to provide temporary living quarters during periods of recreation, camping, or travel. Travel trailers generally have size limits, such as 8 feet

wide and 40 feet long , for an area <320 ft 2 . Travel trailers generally are considered vehicl es rather than structures and are regulated by state transportation authorities rather than by housing authorities. Travel trailers have been used principally for short

- term housing needs. They are placed on private sites while a homeowner’s permanent resi dence is repaired or in group configurations primarily to support displaced renters.

**•** Manufactured homes include mobile homes and park models and are used to meet both short

and long

- term disaster housing needs. Manufactured homes typically are placed on commercial pads or in group sites developed expressly for this purpose.

**•** “ Trailers ” in this report refers collectively to travel trailers, park models, and mobile homes.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 3 Formaldehyde Levels in Residential Indoor Air

F ormaldehyde in homes is a longstanding issue. Formaldehyde frequently is used in plywood, fiberboard, resins, glues, carpets, and several other construction components. In the past, formaldehyde also was used in insulation of many homes. In March 1982, the U.S. Consumer Product Safety Commission (CPSC) called for a ban on urea foam formaldehyde insulation (UFFI) (US CPSC , 1982 ). Although several commercial gr oups challenged this ban, citing

greater formaldehyde exposure from carpets and other building materials, UFFI use had dropped precipitously by the mid 1980s. However, homes built before or around the UFFI ban still had

this insulation.

The 1982 ban on UF FI contribut ed to the decreased levels of formaldehyde in more recent

studies. Changes in the type of pressed wood products containing formaldehyde resins or glues

also contributed to the decrease . In the past, pressed wood products often contained urea

fo rmaldehyde resins. Today these resins are not as widely used. Instead, many pressed wood products are constructed with phenol

- formaldehyde products (commonly known as exterior

grade products). Phenol

- formaldehyde products emit much less formaldehyde (US EP A, 2007).

Temperature, relative humidity (RH) , ventilation, and age of house also contribute to differences in measured formaldehyde levels. In l ongitudinal studies

, formaldehyde emission rates were nearly constant over the first 8 months after constructi on
, and then began to decline, suggesting that formaldehyde off

- gassing continues for extended periods but decreases with the age of the home (Park and Ikeda, 2006). Studies also show that older homes have lower formaldehyde levels than do newer homes (Hod gson et al., 2000; Gordon et al., 1999).

A 1985 U.S. study investigated formaldehyde levels in different types of housing ( Stock and

Mendez

, 1985)

. F ormaldehyde levels in 38 conventional U.S. homes averaged 40 parts per billion (ppb), with highs of 140 pp b . Nineteen apartments and 11 condominiums had average formaldehyde levels of 80 ppb and 90 ppb, respectively, with highs of 290 ppb. A more recent study of new homes found geometric mean (GM) formaldehyde level s of 34 ppb in manufactured homes and 36 ppb in site

- built homes (Hodgson et al., 2000). This study suggested that formaldehyde levels in conventional homes have decreased greatly since the 1980s

, possibly

because of decreased use of plywood paneling and reduced emissions from the composite wood prod ucts used.

T he U.S. Environmental Protection Agency ’s National Human Exposure Assessment Survey found a median formaldehyde level of 17 ppb

, with a high of 332 ppb , in 189 Arizona homes (Gordon et al., 1999). In a recent study of 184 single

- family homes i n three cities, Weisel et al. (2005 ) found mean formaldehyde level s of 3 ppb in outdoor ambient air ; 17 ppb in home indoor

air ; and 16

– 25 ppb in trailers

.

These studies indicate a trend. Even though all homes have some formaldehyde, levels generally

seem to have decreased since the early 1980s. Lower ventilation rates in manufactured homes

and greater ratios of surface area to volume may factor in this trend ( US C PSC , 1997).Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 4 Health Effects

S ymptoms from acute exposure to formaldehyde commonly manifest as irritation of the throat, nose, eyes, skin, and upper respiratory tract. This upper respiratory tract irritation can exacerbate symptoms of asthma and other respiratory illnesses (Main et al., 1983; Bracken et al., 1985; Kilburn et al., 1985; Imbus et al., 1985; Anderson et al., 1979 ; Garret et al,. 1999 1 ; Hendrick and
Lane, 1977 1 ; Institute of Medicine, 2000 1 ; Jaakkola et al., 2004 1 ; Kryzanowski et al., 1990 1 ; McCoy, 2008 1 ; NHLBI et al., 2007 1 ; Nordman et al., 1985 1 ; Rumchev et al., 2002 1 ; Staab et al.,

20 08 1 ; Thompson and Grafstrom , 2008 1 ).

Acute and chronic health effects of exposure to formaldehyde vary by individual. At 800 ppb

, nearly everyone develops some acute irritative symptoms; however, formaldehyde

- sensitive

persons have reported symptoms at le vels around 100 ppb (Main et al., 1983; Bender et al., 1983 ; Hanrahan et al., 1984 1 ). Additional studies have found health effects at 100 ppb in sensitive

persons chronically exposed to formaldehyde (Ritchie et al., 1987 ; ATSDR 2010 1 ). Typically olfactory recognition occurs around 500 ppb, leaving the average exposure from a home below

th is level . Sensitive and sensitized persons can experience symptoms without detecting odor and

thus receive little or no warning of exposure (Kulle et al. 1987; Weisel et al . 2005 ; Fischer et al.,

1995 1 ; Garrett et al., 1999 1 ; Kiec

- Swierczynska, 1996 1 ; Lee et al., 1984 1 ; Maibach, 1983 1 ; Marks et al., 1998 1 ; Wantke and Wantke., 1996 1 ).

In addition to acute health effects from formaldehyde, chronic effects in occupational sett ings

have been studied. A study of 186 male plywood workers associated formaldehyde exposure with several respiratory symptoms

, including cough and chronic bronchitis , and suggest ed that formaldehyde exposure induces symptoms of chronic obstructive lung di sease ( Malaka and

Kodama

, 1990)

. F uneral home workers reported chronic bronchitis more fr equently than did

controls who were not occu pationally exposed to formaldeh y d e (Holness, 1989).

However, studies attempt ing to correlate worker

- reported symptoms, suc h as cough or shortness of breath, with formal objective pulmonary function testing have shown conflicting results. Two

studies demonstrated a small and reversible decrease in forced expiratory volume and forced vital capacity (Alexandersson et al., 1989; Alexandersson et al., 1982). A dditional studies employ ing formal pulmonary function testing demonstrated no significant difference in pulmonary function testing parameters (Horvath, 1988; Holness et al., 1989).

The carcinogenicity of f ormaldehyde has been extensively studied during the last 30 years. In
June 2004, t he International Agency for Research on Cancer (IARC) reclassified formaldehyde from “probably carcinogenic to humans” to “carcinogenic to humans

. ” IARC has concluded that

f

ormaldehyde exposure causes nasopharyngeal cancer ( http://monographs.iarc.fr/ENG/Meetings

/88

- formaldehyde.pdf )

. However, t he National Institutes of Health National Toxicolog y Program has not adopted IARC’s clas sification change and continues to classify formaldehyde as

“reaso nably anticipated to be a carcinogen in human s ” (http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s089form.pdf).

1 CDC added this reference on December 15, 2010 in response to an Information Request f or Correction
( http://aspe.hhs.gov/infoquality/request&response/35b8.pdf )Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 5 H ow to quantitatively relate measured air levels of formaldehyde to cancer risk is uncertain

. Because many other factors play a role in the development of cancer and because formaldehyde is ubiquitous in the environment, no definitive level can be established that places humans in a “high

- risk” category. The safest way to reduce risk for cancer is to limit exposure. Clinically useful biologic markers, such as blood or urine tests, also are lacking, further complicat ing the ability to link exposure with outcome. Because formaldehyde plays integral physiologic roles

and has a short half

- life in the body , determin ing what is necessary for normal p hysiologic function and what is excessive and potentially harmful is difficult (Sullivan and Kreiger, 2001; Baselt, 1994). In general, the lower the level and shorter the duration of exposure, the lower the

risk for cancer and other health effects.

Regula tions and Standards of Formaldehyde Levels

N o federal regulation or standard exists for formaldehyde levels in residential settings.

O ccupational levels are not appropriate to appl y to residential settings for a variety of reasons. For example, residential populations includ e children and elderly persons and thus are more diverse than occupational populations and possibly more susceptibl e to illness from exposure

because of preexisting health conditions. Exposure times and circumstances in homes can vary

su bstantially from those in occupational settings. Many occupational settings have ongoing monitoring programs and may have safety requirements to reduc e formaldehyde exposure (US Department of Labor, 2007). Even for workers, regulations and standards establ ished for formaldehyde by government agencies and other organizations

— such as t he Occupational Safety

and Health Administration

, CDC’s National Institute for Occupational Safety and Health, and the American Conference of Governmental Industrial Hygienists

— differ markedly for both long

and short

- term exposures (Federal Register, 1992 ; NIOSH, 1992 ; ACGIH, 1993)

.

Various nonoccupational standards also vary The U.S. Department of Housing and Urban Development (HUD) regula tes formaldehyde emissions from wood p roducts used in the construction of manufactured housing. HUD ’s maximum allowed levels f or formaldehyde emissions from wood product s are 200 ppb for plywood and 300 ppb for particle board (http://ecfr.gpoaccess.gov). The World Health Organization guideline for formaldehyde in nonoccupational settings is 100 ppb for 30 minutes. This guideline was developed to protect against sensory irritation in the general population, but it also represents an exposure level at which risk for upper respiratory tract cancer in humans is negligible ( WHO, 1989). The State of California Office of Environmental Health Hazard Assessment (OEHHA) guideline for formaldehyde is less than typical ambient levels, it recommended an office level of 23 ppb ( http:// www.oehha.ca.gov/air/chronic_rels/AllChrels.html )

.

OBJECTIVES

The objectives of this study were to

1. Determine formaldehyde levels in occupied trailers.

2. Determine factors or characteristics of occupied trail ers

— not specific to any particular type of trailer

— that could affect formaldehyde levels.

3. Provide information to assist FEMA in making decisions about relocatin g residents from

FEMA

- supplied trailers still used in the Gulf Coast area.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 6 METHODS

To evaluate the formaldehyde levels and to determine potential factors and characteristics of occupied trailers that can impact formaldehyde levels, study investigators collected the following

data for each participating trailer:

**•** A 1

- hour, time

- integrated indoor samp le measurement of formaldehyde.

**•** A concurrent sample measurement of indoor temperature and RH

**•** A short questionnaire administered to adult residents to obtain demographic information about trailer residents and typical daily activities.

**•** A short walk

- through survey to assess the indoor environment and the home exterior.

Study Personnel

S taff who collected the data were contractors from Bureau Veritas (Kennesaw, GA). Their

t rain ing at the beginning of the study included review of recruitment, data collection, trailer visits, data records, and the protocol. CDC staff monitored contract staff throughout the study

and were always available for consultation.

Trailer Selection Using d isproportionate stratified random sampling , CDC investigators select ed 519 trailer s for

p articipation from a FEMA

- provided list of 46,970 trailers in LA and M S that were identified as occupied as of November 2007. SAS 9.1 was used to randomly generate a list of sample trailers.

The three trailer types most commonly used

— travel trailer , park model, and mobile home

— were divided into a total of 11 strata

. T ravel trailer s comprised seven strata : th e top six manufacturers (Gulfstream, Forest River, Fleetwood, Fleetwood CA, Pilgrim, and Keystone [ which together represented 61% of occupied tr avel trailers ] ) and “ all other ” travel

- trailer brands. Because Gulfstream was the most frequently used travel trailer , that brand was oversampled. P ark model s comprised two strata: the most common model manufactured by Silver Creek ( 21% of park

models ) and “ all other ” park model manufacturers. M obile home s also comprised two strata: the most common model manufactured by Cavalier ( 17% of mobile homes used ) and “ all other ”

manufacturers. Each brand in the “ all other” groups made up < 3% of the trailers

.

The n umber of trailers selected was based on power calculations that allow researchers to draw statistically valid conclusions about the population of occupied trailers studied (i.e., FEMA

supplied trailers used) and for common trailer types and brands within t hat population of FEMA

supplied trailers. With a level of significance of 5% (95% confidence) and power of 80%, the goal was to sample a minimum of 38 trailers to detect an average difference of 30 ppb for each

strat um

. S ample sizes were calculated as test s for each strat um mean again st the mean for the entire sample.

Within each strat um , each trailer was assigned a random number (e.g., SAS:

Randval=randuni [ number ] ). Each list then was sorted in numeric order according to the random number assignment. In r ecruiting eligible households, investigators followed a specific protocol (Appendix A) and used these ordered active call lists to recruit participants for the study, beginning with number 1 and ending with number 120 for the Gulfstream strat um and withFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 7 nu mber 38 for each of the other 10 strata. W hen the occupant of a selected trailer could not be contacted, declined participation, or was ineligible , investigators called the next trailer o n the list, adding trailers as necessary from a reserve list, until t hey had successfully enrolled 120 trailers in

the Gulfstream strat um and 38 trailers in each of the other 11 strata.

Up to three telephone numbers were provided for each trailer. Over a 1

- week period

, investigators attempted a total of 15 times separate a ttempts to contact a selected trailer. The 15 attempts included various times of the day and days of the week. If unsuccessful after 15 attempts, the trailer was moved to the “unable to contact” list and a new trailer from the reserve

list was added to the active call list.

Contract staff followed a phone script (Appendix B) when speaking with the self

- identified adult resident and recorded each attempt in a phone log (Appendix B). If the adult resident of an eligible household agreed to participate, a tim e was scheduled to conduct the sampling. If the adult resident declined to participate, the trailer was moved to the “refused to participate” list and

a new trailer from the reserve list was added to the active call list.

S ome enrolled households were ex pected to not complete the study for a variety of reasons. Each time it was determined that an enrolled trailer was to be removed from the list of participants, a new trailer from the reserve list was substituted and recruitment procedures as described abo ve were followed.

Eligibility Criteria Adult residents who agreed to participate were enrolled in the study. Eligibility criteria for participation in the study specified that:

**•** The consenting adult resident was ≥ 18 years of age.

**•** The adult resident resi ded in a FEMA

- issued trailer in MS or LA at the time of phone

recruitment.

**•** The adult resident reported that he or she spent at least 6 hours each day in a FEMA

issued trailer.

**•** The adult resident agreed to participate.

Consent/Assent Process

Adult resident s provided i nformed assent (Appendix C) which was first obtained from the contacted adult resident during the scripted recruitment phone call. A second informed consent form was provided to the participant and signed in person sample collection (Appendix D ). A ll participants received appropriate notification of confidentiality. CDC ’s Institutional Review Board reviewed and approved this study (CDC Protocol #5320, approved by CDC IRB

- G on December 20, 2007)

.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 8 Variables The primary outcome variable was the 1

- hour average level of formaldehyde measured in the air of occupied trailers. To determine potential factors of occupied trailers that can affect the measured formaldehyde levels, other variables were collected during an exposure assessment and

walk

- throug h

.

Exposure Assessment Questionnaire Investigators administered a short questionnaire (Appendix E) to the adult resident during the 1

- hour sample collection process. The questionnaire inquired about the demographics of the trailer

occupants and the averag e number of hours spent inside and outside the trailer. It also inquired

about factors that can influence the indoor environment of the trailer , such as occupant smoking and frequency of air conditioning, heating

, and window use. Daily and recent activitie s in the

trailer , such as cooking, also were recorded.

Environmental Walk

- Through Survey During the walk

- through survey (Appendix E), investigators surveyed the interior and exterior of

the trailer , observing such factors as holes and leaks, mold, type of cooking fuel, and working

smoke detectors.

Formaldehyde Sample Collection Investigators and FEMA field workers were present for each scheduled sampling appointment. Investigators collect ed a 1

- hour sample of air in each participating trailer using the NI OSH Manual of Analytical Methods Method 2016 using Supelco S10 LpDNPH cartridges (St. Louis, MO) ( http://www.cdc.gov/niosh/nmam/pdfs/2016.pdf ). S taff also measured indoor temperature

and RH . In an attempt to standardize living conditions between trailers, residents were asked to configure doors and windows as they would have them while they slept. No cooking or smoking was allowed in the travel trailers or mobile homes during the 1

- hour sample collection period

because these activities could affect formalde hyde levels.

Samples were collected using standard industrial hygiene pumps

. S amples were drawn at a flow

rate of 500±50 mL per minute for 1 hour at a height of 4 feet

, which is comparable to a person’s breathing zone while sitting. A n investigator observ ed sample collection at all times. Investigators followed all quality assurance and quality control standards as outlined in the standard operating procedures for field collection (Appendix F).

Samples were analyzed for formaldehyde levels at the Bureau V eritas laboratory in Novi,

M ichigan . The Bureau Veritas laboratory is a contract laboratory for NIOSH and follows NIOSH data quality objectives in its sampling and analysis.

Temperature and Relative Humidity Sample Collection

A concurrent 1

- hour reading o f temperature and RH was collected in the center of the trailer primary living room using a HOBO ® temperature and RH logging instrument manufactured by Onset Computer Corporation (Bourne, MA). The instrument collect ed data at 5

- minute intervals.

Data were collected for a minimum of 70 minutes, beginning at least 5 minutes before and lasting at least 5 minutes after collection of the formaldehyde sample at each trailer.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 9 Sample Collection Data Sheet Investigators completed a data sheet (Appendix G) for forma ldehyde, temperature, and RH. Information included sample start and finish time, location of sample collection, and flow calibration results before and after sample collection was recorded. The data sheet accompanied the questionnaire and the walk

- through survey (Appendix E).

Data Collection , Entry, Editing, and Management Investigators collected a ll questionnaire, survey, and field data ; labeled all samples and documentation with a unique alphanumeric identifier ; and logged all paperwork and samples as

th ey completed each trailer. Strict quality assurance and quality control procedures were

observed.

Investigators entered a ll field data into an electronic data base

. All participant information remained confidential and was used only for the study. Access t o data was restricted to those involved in conducting the study. In addition, all reports

— published and internal

— were based only on aggregate data. Investigators returned or destroyed all data sources after deliver ing the final approved database to CDC.

S tatistical Analysis All statistical analyses were conducted using SAS 9.1. The SURVEYMEANS, SURVEYREG, and SURVEYFREQ procedures were used to account for the stratified sampling design. Unweighted frequencies of questionnaire items were calculated using th e FREQ procedure.

Data were examined and potential misclassifications of trailers resolved. The manufacturer, manufacturer’s vehicle identification number, and trailer type were examined to confirm the

c a tegorization of each trailer . In cases where a trai ler was recategorized, two independent evaluators agreed on the new classification.

A natural log transformation was applied to the formaldehyde levels to normalize the distribution. Tests for normality were conducted on the transformed levels

, and the levels were plotted to examine the form of the distribution. Univariate linear regression models were constructed to evaluate the significance of selected questionnaire items in predicting the natural log of formaldehyde levels. Variables with cell counts of five or fewer were not included in the regression models.

Temperature and RH were evaluated separately as both continuous and categorical variables.

R ecorded signs of mold in the living area of the trailer were used to create a dichotomous

variable ind icating whether the trailer had < 1 ft 2 of mold versus > 1 ft 2 of mold.

Because t he SAS SURVEYREG procedure does not include an option for automated model

selection , CDC staff manually performed a backward elimination procedure. All independent

variables wi th cell counts greater than five initially were entered into the linear regression model. At each step

, the variable contributing the least to the model, as assessed by the F statistic, was

removed. The final model included variables that were significant at a P of < 0.05.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 10 RESULTS

Participation Rates

D uring recruitment

, investigators contact ed residents at 1137 (76%) of the 1489 trailers on the

FEMA

- supplied list (Figure 1) . Of the 717 eligible trailers, occupants in 519 ( 72% ) participat ed

. Reasons for in eligibility of the remaining 420 trailers included trailer no t occupied ( 367 [ 87% ] ) ; trailer type no longer needed for its strat um ( 27 [ 6% ] ) ; trailer occupant unable to schedule an appointment time because of work, travel, hospitalization, or other reasons ( 15 [ 4% ] ) ; hostil ity by occupants ( 3 [ 1% ] ) ; and unknown reasons ( 8 [ 2% ] )

.

Most trailers sampled were in L A and were located on private land (Table 1 )

. Most were issued

in 2005 and therefore were at least 2 years old at the time of testing. Seventy

- seven percent of total occupants were adults. Recategorization of trailers resulted in reclassification of 35 trailers (7%) to new strata. The majority of these reclassified trailers came from the nonspecific “other”

strata.

Overall Range and Variability of Fo rmaldehyde Levels

The geometric mean (GM) formaldehyde level for all trailers sampled was 77 ppb ( 95%

c onfidence i nterval [ CI ]: 70

– 85 ; range : 3

– 590 ppb )

. Throughout this report, when mean formaldehyde levels are discussed they will refer to GM formaldehyde levels. The GM formaldehyde level was 81 ppb for travel trailers (95% CI: 72

– 92), 44 ppb for park models (95%

CI: 38

– 53) and 57 ppb for mobile homes (95% CI: 49

– 65) (Figure 2). GM formaldehyde levels varied significantly among travel trailers, park models , and mobile homes ( P < 0.001) and ranged widely in all types of trailers. In a ll three trailer types

, some trailers had formaldehyde

levels ≥ 100 ppb. Mobile home s and travel trailers each had levels ≥ 300 ppb (Table 2 ). GM formaldehyde levels differed si gnificantly among strata , but each stratum included some trailers

with levels ≥ 100 ppb (Table 3 ).

Occupant Activities The investigation included o ccupant activities in the trailers (Table 4 ). A ir conditioning was used

< 4 hours per day in 71%; h eat was us ed < 4 hours a day in 56% ; and s pace heaters were used in

44%. For 34% of trailers , r esidents reported someone had smoked in the trailer within 2 weeks

before the sampling. Eighty

- one percent of respondents cooked in their trailer s . Pets were present
in 25 % of trailers

, with dogs (20%) most common ly reported

. More than 80% of respondents

spent > 8 hours in their trailer each day.

Occupant activities directly preceding the sampling period were recorded to determine whether they significant ly affect ed sampling results. Within 3 hours before testing, 44% of homes had

windows , doors, and scuttles open , and smoking had occurred in 19%. Other activities in the week before testing included us e of air fresheners (61%); candles (24%); and glue, paint, or

furniture fin ish (3%) . These finding did not correlate with any specific type of trailer.

Trailer Characteristics Specific characteristics of each sampled trailer were recorded. Respondents reported roof leaks in 17% of trailers, pipe leaks in 15%, and mold in 21%.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 11 W alk

- Through Survey On the day of sampling, investigators wa lk ed through each trailer to record specific characteristics and information (Table 5 ). Propane gas was the most commonly used fuel for cooking ( 71% of trailers )

. Six percent of trailers ha d at lea st 1 ft 2 of mold. Twenty

- nine percent of trailers did not have a functioning smoke detector.

Multivariate Analysis

B ackward elimination modeling yielded a final regression model containing the following statistically significant variables: stratum ( P < 0. 0 0 01) ; average temperature in degrees F ( P <
0 .0001) ; RH expressed as a percent age ( P < 0.0 0 01) ; a dichotomous variable indicating whether doors, windows, or scuttles were open in the 3 hours before testing ( P = 0.02) ; and a dichotomous variable indicating the amount of mol d observed in the trailer ( ≥ 1 ft 2 ) ( P = 0.05). The dependent variable was the natural log of the formaldehyde levels . Temperature accounted

for the most variation in the natural log of formaldehyde levels explained by the model ( Figures

3 and 4 ) show the unadjusted relationship between the natural log of formaldehyde and temperature and humidity, respectively

. T emperature ranged from 41o F to 91oF

, and RH was 23%

– 88%.

Temperature and RH were evaluated separately as both continuous and categorical variables

. R esults were similar

, so investigators include d the continuous variables in the final model.

I nteractions between independent variables were not significant

.

The presence of > 1 ft 2 of mold was associated with a significant increase in GM formaldehyde

le vels (adjusted mean 86 ppb versus 63 ppb) (Table 6 ). W indows, doors, or scuttles open in the 3

hours before testing was associated with a significant decrease in GM formaldehyde levels (adjusted mean 65 ppb versus 83 ppb) (Table 7 ). Although each of three strata (Forest River, other park models, and other mobile homes) contained fewer than 38 trailers , contrasts comparing the GM formaldehyde level in each of them to the overall GM of the others still showed significant differences ( P = 0.01, 0.01, and 0.04, respectively).

GM formaldehyde levels in t ravel trailers manufactured by Fleetwood and Fleetwood CA were significantly lower than levels in the other travel trailers combined, after adjust ment for covariates ( P < 0.001 for both). They did not differ sign ificantly from each other. GM formaldehyde levels for Pilgrim, Keystone, and Gulfstream were significantly higher than for the

other travel trailers combined

, after adjust ment for covariates ( P <0.001 for all three). They did

not differ significantly from e ach other. After adjust ment for covariates, levels in Silver Creek

p ark models were significantly lower than those in other park models ( P = 0.004)

, and levels in

Cavalier m obile h omes were significantly higher than those in other mobile homes ( P = 0.006). Table 8 presents the adjusted GM formaldehyde level by stratum from the multivariate model.

The parameter estimates ( Table 9 ) can be used to calculate predicted formaldehyde levels

. However, extrapolating beyond observed levels is not recommended. As an example, a Keystone travel trailer with an average temperature of 65oF ; an average RH of 45% ; no open doors, windows, or scuttles in the 3 hours before testing ; and mold ( ≥ 1 ft 2 ) would have a predicted formaldehyde level of 88.5 ppb:Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 12 Natural log of formal dehyde = 0.012 + 0.096 + 65(0.052) + 45(0.017) +0(

- 0.243) + 0.311 Predicted formaldehyde: 88.5 ppb

DISCUSSION

Formaldehyde levels in the trailers in this study were higher than average levels in U.S. mobile homes and traditional homes reported in recent studies ( Weisel et al. , 2005; Gordon et al., 1999 ). As the formaldehyde level rises, risk for health consequences presumably also rises. At higher levels, people can have acute symptoms

, such as coughing and irritated eyes, nose, throat, and upper respirat ory system. Even at levels too low to cause such symptoms, risk for cancer can increase

. N o specific level of formaldehyde separates "safe" from "dangerous

, ” especially in regard to cancer.

In this study, certain human activities were associated with high er formaldehyde levels. Open

windows , doors, or scuttles decrease d formaldehyde levels , indicating ventilation of trailers is an important recommendation to occupants. Keeping windows , doors, or scuttles open and the us ing air conditioning were associated with decreased levels of formaldehyde in trailers in a previous study (ATSDR, 2007). Yet many trailer air conditioners recirculate air and do not provide

outside ventilation. Thus, less use of air conditioning may indicate increased ventilation because

doo rs
, windows , and scuttles are more likely to be open. R esults of this study show a low use of air conditioning during the study period. Most trailers ha d working air conditioning, but most people did not use it more than 4 hours each day , most likely becau se the study was conducted during the winter ; other factors could include cost and noise.

Smoking by occupants, though not significantly associated with increased formaldehyde levels in the multivariate analysis, was common and remains an important issue because cigarettes are a source of formaldehyde. Cigarette smoke also contains a wide range of other toxic and irritating compounds associated with increased health risk that can worsen air quality in the trailers.

The pr esence of mold ( ≥ 1 ft 2 ) ( 6 % of trailers ) was associated with higher formaldehyde levels.

Mold also can contribute to decreased indoor air quality and cause respiratory symptoms.

Cooking, particularly without outdoor

- venting range hoods, can affect formal dehyde levels

. T he unvented combustion from gas

- fired stoves can be a source of formaldehyde and other air pollutants and can increase the temperature and RH inside the trailer.

Increased indoor temperature and RH were associated with increase d formaldehy de levels. These associations indicate exposure risks could increase during the summer, perhaps dramatically, with warmer and more humid weather. Formaldehyde levels during the winter may not represent

summer levels.

Stratification was conducted to assess the possibility of an elevated formaldehyde level in one brand or a group of brands. Some brands show ed higher GM formaldehyde levels than others,

al though this study showed all brands with some trailers ≥ 100 ppb, levels at which health effects

have been described in sensitive persons

. Formaldehyde levels varied by trailer type, but allFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 13 types tested had some levels ≥ 100 ppb (Ritchie et al., 1987; Main et al., 1983; Bender et al., 1983).

LIMITATIONS

S tudy results are not representative of trailers purch ased and used in other places and other situations because the sample for this study was selected only from occupied FEMA

- supplied

trailers in LA and MS. Formaldehyde levels in o ther trailers used elsewhere could differ by age, characteristics of manufactu re, circumstances of use, or characteristics of environment.

Formaldehyde levels are expected to be lower in cooler temperatures and lower RH because of the processes of formaldehyde off

- gassing. Therefore, levels measured in this study are likely to

unde restimate past levels

— when trailers were hotter and more humid

— and future levels

— during summer months. Many of these trailers were > 2 years old

, and previous studies have

shown highest formaldehyde levels in newer trailers and homes (Hodgson et al., 2000; Gordon et al., 1999)

, so residents were probably exposed to higher levels of formaldehyde when their

trailers were newer

.

F ormaldehyde was measure d at a central location in the trailer

, and different locations in the

trailer could have different formaldeh yde levels . H owever , as a gas
, formaldehyde is likely to diffuse evenly throughout the trailer. T he results of this study do not apply to trailers used in other places and situations because this representative sample was selected only from FEMA

supplied t railers in L A and M S

. This study does not assess the health status of people currently living in FEMA trailers, but further studies are planned to investigat e potential health effects from living in trailers.

CONCLUSIONS

1. In many trailers tested, formaldeh yde levels were higher than typical U.S. indoor levels

. 2. The average level of formaldehyde in all trailers was 77 ppb

, and many trailers had higher levels ( rang e: 3 ppb

– 590 ppb ) . These are higher than U.S. background levels, and occupant health could be af fected at the levels recorded in many trailers.

3. These measured levels probably underrepresent occupant exposures in the early months of occupation and even the average exposure over time the trailers were occupied because formaldehyde levels tend to be hig her in newly constructed trailers and during

warm weather.

4. Higher indoor temperatures and RH were associated with higher formaldehyde levels in this study

, independent of trailer type or brand.

5. Formaldehyde levels varied by trailer type, but all types test ed had some levels ≥ 100 ppb , at which acute health effects can occur in sensitive persons

. 6. Travel trailers had significantly higher average formaldehyde levels than park models or mobile homes. Travel trailers also had higher proportions of trailers with formaldehyde

levels ≥ 100 and ≥ 300 ppb than park models or mobile homes.

7. Because some types and brands had lower average formaldehyde levels, trailers might be

able to be manufactured or used in ways that reduce levels . Additional studies are under way to address this possi bility

. 8. Factors such as temperature ; RH ; closed windows , doors, and scuttles ; and presence ofFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 14 mold ( ≥ 1 ft 2 ) were associated with increased formaldehyde levels in the trailers. These were not assessed with respect to any specific type of trailer.

9. Only 71% of trailers sampled had a working smoke detector. E ducation is needed about the need for smoke detectors in the trailers and testing to ensure they function correctly

.

RECOMMENDATIONS

Recommendations for Public Health, Emergency Response, and Housing Offi cials

1. These conclusions support decisions made need to relocate residents of the U.S. Gulf Coast region displaced by hurricanes Katrina and Rita who still live in trailers move quickly before temperatures in the region increase d

. On the basis of observ atio ns and previous scientific literature , priority should be given as follows:

a. Persons currently experiencing symptoms possibly attributable to formaldehyde

exposure
,

b. E specially vulnerable persons (e.g., children, the elderly, and those with chronic diseases) , and

c. Persons living in trailer types that tend to have higher formaldehyde levels.

2. Follow

- up will require collaboration among multiple agencies

— including FEMA, HUD,
CDC, and state and local officials

— to achieve safe, healthy housing for people displaced

b y hurricanes Katrina and Rita who continue to live in FEMA

- supplied trailers

. 3. Follow

- up will require multiagency collaboration involving HUD, CDC, and others to assess the potential for formaldehyde levels in trailers used in other places and contexts,

inc luding trailers used for recreation, permanent housing, schools, and offices.

4. Federal, state, and local officials should consider how best to provide necessary assistance to the Louisiana and Mississippi state health departments to ensure adequate

follow

- u p, including medical needs, for residents with health and medical concerns resulting from formaldehyde exposure while residing in FEMA

- provided travel trailers, park models, and mobile homes.

5. Federal, state, and local officials should consider supporting establishment of a registry of people who resided in FEMA

- supplied trailers in the U.S. Gulf Coast region.

Recommendations for Residents Awaiting Relocation

1. Spend as much time as possible outdoors in fresh air.

2. Open windows , doors, and scuttles as often a s possible to let in fresh air.

3. Try to maintain the temperature inside trailers at the lowest comfortable level.

4. Do not smoke, especially not inside.

5. If you have health concerns, see a doctor or another medical professional.

6. All of these recommendations a pply particularly to families with children, elderly

persons , and those with chronic diseases

, such as asthma.

Further CDC Action

1. CDC notified participants about their study results by personal visits from members of

the U.S. Public Health Service Commiss ioned Corps and FEMA representatives and by

hand

- delivered letters.

2. At a series of 14 public availability sessions in L A and M S , CDC staff were available to

talk with concerned and interested persons
, provide information

, and answer questions.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 15 3. CDC is asses sing formaldehyde levels across different models and types of unoccupied trailers to identify factors that decrease or increase those levels. This assessment also involves identifying cost

- effective ways to reduce formaldehyde levels in trailers.

4. CDC is de veloping a protocol for a long

- term health study, with a respiratory focus, of

children who resided in FEMA trailers and mobile homes in LA and M S

. 5. CDC provided educational materials and information to trailer residents about their risk for exposure to for maldehyde and ways to improve indoor air quality and health.

6. CDC reconvened a panel of experts on this issue to identify and provide input on health issues potentially associated with long

- term residence in trailers.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 16 REFERENCES

[ATSDR] Agency for Toxic S ubstances and Disease Registry. 2007. An Update and Revision of ATSDR’s February 2007 Health Consultation: Formaldehyde Sampling of FEMA Temporary

Housing Trailers

, Baton Rouge, Louisiana, September

– October 2006. [cited October 2007].

Available from: http://www.atsdr.cdc.gov

.

[ATSDR] Agency for Toxic Substances and Disease Registry. (1999). "Formaldehyde." Toxic

Substances Portal Retrieved June 29, 2010, from
www.atsdr.cdc.gov/substances/toxsubstance.asp?toxid=39

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Alexandersson R, Hedenstierna G, Kolmodin

- Hedman B. 1982. Exposure to formaldehyde: effects on pulmonary function. Arch Environ Health;37(5):279

– 84.

Alexandersson R, Hedenstierna G. 1989. Pulmonary function in wood workers exposed to formaldehyde: a prospective study. Arch Environ Health 44(1):5

– 11.

[ACGIH] American Conference of Governmental Industrial Hygienists. 1993. ACGIH announces change in formaldehyde TLV (threshold limit v alue). Health Hazard Mater Manage

6 (6):6

– 7.

Anderson RC, Stock MF, Sawin R, Alarie Y. 1979. Toxicity of thermal decomposition products of urea formaldehyde and phenol formaldehyde foams. Toxicol App Pharmacol 51(1):9

– 17.

Baselt RC, Cravey RH. 1994. Dispos ition of toxic drugs and chemicals in man. 4th ed

. , Formaldehyde

. 346

– 48.

Bender JR, Mullin LS, Graepel GJ, Wilson WE. 1983. Eye irritation response of humans to formaldehyde. AIHA J 44(6):463

– 5.

Bracken MJ, Leasa DJ, Morgan WK. 1985. Exposure to formaldeh yde: relationship to respiratory symptoms and function. Can J Public Health 76(5):312

– 6.

Federal Register. 1992. Occupational exposure to formaldehyde

— OSHA: Response to Court Remand; Final Rule. 102 Federal Register 22290

– 328.

Fischer, T., K. Andersen, et al. (1995). "Clinical standardization of the TRUE Test formaldehyde
patch." Current Problems in Dermatology 22 : 24

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Garrett, M., M. Hooper, et al. (1999). "Increased Risk of Allergy in Children Due to

Formaldehyde Exposure in Homes." Allergy

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http://aspe.hhs.gov/infoquality/request&response/35b8.pdfFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 17 Gordon SM, Callahan PJ, Nishioka MG, Brinkman MC, O'Rourke MK, Lebowitz MD. 1999. Residential environmental measurements in the national human exposure assessment survey (NHEXAS) pilot study in Arizona: preliminary results for pesticides and VOCs. J Exposure Anal Environ Epidemiol 9(5):456

– 470.

Hanrahan, L., M. Kay, et al. (1984). "Formaldehyde Vapor in Mobile Homes: A Cross Sectional Survey of Concentrations and Irritant Effects." American Journal of Public Health 74 : 1026

- 1027 3

Hendrick, D. and D. L ane (1977). "Occupational Formalin Asthma." British Journal of Industrial

Medicine

Hodgson AT, Rudd AF, Beal D, Chandra S. 2000. Volatile organic compound concentrations

and emission rates in new manufactured and site

- built houses. Indoor Air 10(3): 178

– 92. 34 : 11

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Holness DL, Nethercott JR. 1989. Health status of funeral service workers exposed to formaldehyde. Arch Environ Health 44(4):222

– 8.

Horvath EP Jr, Anderson H Jr, Pierce WE, Hanrahan L, Wendlick JD. 1988. Effects of formaldehyde on the mucous membranes and lungs: a study of an industrial population. JAMA 259(5):701

– 7.

Imbus HR. 1985. Clinical evaluation of patients with complaints related to formaldehyde exposure. J Allergy Clin Immunol 76(6):831

– 40.

Institute of Medicine (2000). Clearing the Air: Asthma and Indoor Exposures. Washington DC, National Academy of Sciences. 3

International Agency for Research on Cancer. 2004. Press Release N 153; June 15. Available from: http:// www.iarc.fr/ENG/Press_Releases/archives/pr153a.html.

Jaakkola, J. J., H . Parise, et al. (2004). "Asthma, Wheezing, and Allergies in Russian

Schoolchildren in Relation to New Surface Materials in the Home." American Journal of Public

Health

Kiec

- Swierczynska, M. (1996). "Occupational allergic contact dermatiti s in Lodz:1990

- 1994." 94 (4): 560

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Occup Med

Kilburn KH, Warshaw R, Boylen CT, Johnson SJ, Seidman B, Sinclair R, et al. 1985. Pulmonary
and neurobehavioral effects of formaldehyde exposure. Arch Environ Health 40(5):254

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3 CDC added this reference on December 15, 2010 in response to an Information Request for Correction http://aspe.hhs.gov/infoquality/request&response/35b8.pdfFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 18 Krzyzanowski, M., J. J. Quac kenboss, et al. (1990). "Chronic respiratory effects of indoor
formaldehyde exposure." Environmental Research 52 (2): 117

- 125. 3

Kulle TJ, Sauder LR, Hebel JR, Green DJ, Chatham MD. 1987. Formaldehyde dose

- response in
healthy nonsmokers. JAPCA 37(8):919

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Lee, H. K., Y. Alarie, et al. (1984). "Induction of formaldehyde sensitivity in guinea pigs." Toxicology and Applied Pharmacology 75 (1): 147

- 155. 4

M aibach, H. (1983). Formaldehyde: effects on animal and human skin. Formaldehyde Toxicity

Main DM, Hogan TJ. 1983. Health effects of low

- level exposure to formaldehyde. J Occup Med 25(12):896

– 900. . J. Gibson. Was hington DC, Hemisphere Publishing Corporation : 166

- 174. 4

Malaka T, Kodama AM. 1990. Respiratory health of plywood workers occupationally exposed to formaldehyde. Arch Environ Health 45(5):288

– 94.

Marks, J., D. Belsito, et al. (1998). "North American Contact Dermatitis Group patch test results for the detection of delayed

- type hypersensitivity of topical allergens." J Am Acad Dermatol

Mc Coy, J. T. (2008). Formaldehyde. 38 : 911

- 918. 4

Spacecraft Maximum Allowable Concentrations for

Selected Airborne Contaminants

[NHLBI et al,.] Nationa l Heart, Lung, and Blood Institute, and National Asthma Education and Prevention Program Expert Panel (2007). Expert Panel Report 3:Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD, US Department of Health and Human Services,

National In stitutes of Health. 4 . C. o. T. Committee on Spacecraft Exposure Guidelines, National Research Council, National Academies Press. 5: 206

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[NIOSH] National Institute for Occupational Safety and Health. 1992. Recommendations for Occupational Safety and Health: Compendium of Policy Documents and Statements. Available

from: http://www.cdc.gov/niosh/92

- 100.html

.

Nordman, H., H. Keskinen, et al. (1985). "Formaldehyde asthma

-- Rare or overlooked?" J Allergy Clin Immunol

Park JS, Ikeda K. 2006. Variations of formaldehyde and VOC levels during 3 years in new and

o lder homes. Indoor Air (16):129

– 135 75: 91

- 99. 4

Ritchie IM, Lehnen RG. 1987. Formaldehyde

- related health complaints of residents living in

mobile and conventional homes. Am J Public Health 77(3):323

– 8.

4 CDC added this reference on December 15, 2010 in response to an Information Request for Correction http://aspe.hhs.gov/infoquality/request&response/35b8.pdfFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 19 Rumchev, K., J. Spickett, et al. (2002). "Domestic Exposure to For maldehyde Significantly Increases the Risk of Asthma in Young Children." European Respiratory Journal 20 (403

- 408). 5

Staab, C., M. Hellgren, et al. (2008). "Dual Functions of Alcohol dehydrogenase 3: implications with focus on formaldehyde and S

- nitrosolglu tathione reductase activities." Cellular and

Molecular Life Sciences

Stock TH, Mendez SR. 1985. A survey of typical exposures to formaldehyde in Houston area

residences. AIHA J 46(6):313

– 7. 65 : 3950

- 3960

. 5

Sullivan JB, Krieger GR. 2001. Clinical environme ntal health and toxic exposures. 2nd ed. Formaldehyde 1006

– 14.

Thompson, C. M. and R. C. Grafstrom (2008). "Mechanistic Considerations for Formaldehyde

Induced Bronchoconstriction Involving S

- Nitroglutathione Reductase." Journal of Toxicology

and Environme ntal Health Part A

[US CPSC] US Consumer Product Safety Commission 1982. Release # 82

- 005. Available from: 71 : 244

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http://classaction.findlaw.com/recall/cpsc/files/1 982mar/82005.html

.

[US CPSC] US Consumer Product Safety Commission. 1997. An update on formaldehyde. 1997 Revision. Available from: http://www.cpsc.gov/cpscpub/pubs/725.pdf.

US Department of Labor. Occupational Exposure to Formaldehyde. 2007. http://www. pp.okstate.edu/ehs/training/OSHAFHYD.HTM.

[US EPA] US Environmental Protection Agency. 2007. Indoor Air Quality

— Formaldehyde.

Retrieved from http://www.epa.gov/iaq/pubs/insidest.html#Look6 on January 15th, 2008.

Wantke, F. and Wantke (1996). "Exposure to gaseous formaldehyde induces IgE

- mediated sensitization to formaldehyde in school

- children." Clinical and experimental allergy

Weisel CP, Zhang J, Turpin BJ, Morandi MT, Colome S, Stock TH, et al. 2005. Relationships of indoor, outdoor, and personal air (RIOPA). Part I. Collection methods and descriptive analyses. Research Report (Health Effects Institute) (130 Pt 1):1

– 107; discussion 109

– 27. 26 (3): 276

. 5

[WHO] World Health Organization. 1989. Environmental health criteria for formaldehyde. Geneva, Switz erland: World Health Organization ; Volume 89.

5 CDC added this reference on December 15, 2010 in response to an Information Request for Correction

htt p://aspe.hhs.gov/infoquality/request&response/35b8.pdfFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 20 Figure 1. Recruitment of Participants in a Study of Occupied FEMA

- Supplied Trailers in Louisiana and Mississippi, December 2007

– January 2008

Contact Attempted

in 1489 Trailers

352 (24%)

Trailers Excluded: Wrong # or

Disconnected Phone 1137 (76%)

Trailers Contacted

420 ( 37%) Trailers Ineligible 717 (63%) Trailers Eligible

101 (14%)

Refused Participation

by Phone 616 (86%) Agreed to Participate

97 (16 %)

Refused at Time

of Sampling 519 ( 84 %) Accepted and Tested Cooperation Rate:

519/717 = 72%Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 21 Figure 2. Geometric Mean Formaldehyde Levels in Occupied FEMA

- Supplied Trailers, Louisiana and Mississippi, December 2007–January 2008

GM = g eometric m ean; ppb = parts per billion (divide by 1000 to get parts per million); CL = c onfidence l imit. 0 10 20 30 40 50 60 70 80 90 100Formaldehyde (ppb)

All Occupied

Trailers Travel Trailers Mobile Homes Park Models

− Upper 95% CL

− Lower 95% CL Geometric MeanFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 22 Figure 3. Association of Indoor Temperature with Natural Log Formaldehyde Levels in Occupied FEMA

- supplied Trailers in Louisiana and Mississippi, December 2007

– January 2008

Range: 41oF–91oF 0 1 2 3 4 5 6 7

40 50 60 70 80 90 100

Temperature (oF)Ln Formaldehyde LevelsFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 23 Figure 4. Association of Indoor Relative Humidity with Natural Log Formaldehyde Levels in Occupied FEMA

- supplied Trailers in Louisiana and Mississippi, December 2007–January 2008

Range: 23%–88% relative humidity. 0 1 2 3 4 5 6 7

20 30 40 50 60 70 80 90

Relative Humidity (%)Ln Formaldehyde LevelsFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 24 Table 1 . Demographics of Trailers and Occupants in 519 Occupied FEMA

- Supplied Trailers in Louisiana and Mississippi, December 2007

– January 2008

Category Variable No. (%) Weighted (%)

State Louisiana 408 79 80 Mississippi 111 21 20

Trailer

l ocations P rivate l and 374 72 7 7

P ublic land 127 24 20

Unknown/Undetermined 18 3 3

Year trailer

was manufactured 2005 258 50

-- 2006 128 25

-- Unknown 1 33 26

-- Residents

-- -- No. adult residents (age > 18 years ) 852 77

--

No. teen residents (age 13 ≤ 17 years ) 97 9

--

No. child residents (age 3 ≤ 12 years ) 120 11

--

No. baby residents (age < 2 years ) 41 4

--

Average no

. residents per trailer 2

-- --

Utilities Paid by o ccupant 420 81 8 3 Paid by FEMA 90 17 1 6 Paid by other 9 2 1Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 25 Table 2. Formaldehyde Levels in 519 Occupied FEMA

- Supplied Trailers in Louisiana and Mississippi,

December 2007

– January 2008

GM = Geometric mean; ppb = parts per billion (divide by 1000 to get parts per million); CI = confidence interval. Trailer Type N o. Formaldehyde GM (ppb) Range (ppb) 95% CI for GM (ppb) Weighted Percentage of the Sample with Levels

≥ 100 ppb ≥ 30 0 ppb

Travel

trailer 360 81 3

– 590 72

– 92 42% 5%

Park

model 90 44 3

– 170 38

– 53 14% 0%

Mobile

home 69 57 11

– 320 49

– 65 9% <1%Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 26 Table 3

. Formaldehyde Levels by Manufacturer in 519 Occupied FEMA

- Supplied Trailers in Louisiana and Mississippi,

December 2007

– January 2008

GM = g eometric m ean; ppb = parts per billion (divide by 1000 to get parts per million) ; CI = confidence interval. Home Type Brand N o. in

stratum No. in sample Formaldehyde GM (ppb) Range (ppb) 95% CI for GM (ppb) Weighted Percent age of the S ample with L evels

≥ 100 ppb ≥ 300 ppb

Travel

trailer Gulfstream 14,624 123 104 3

– 590 88

– 123 56% 9%

Forest River 3,220 36 82 17

– 510 61

– 109 42% 6%

Fleetwood 2,371 47 39 3

– 140 32

– 48 6% 0%

Fleetwood CA 1,699 39 43 7

– 300 34

– 55 13% 3%

Pil grim 1,584 39 108 25

– 520 85

– 136 51% 3%

Keystone 1,395 38 102 23

– 480 79

– 131 53% 11%

Other 15,637 38 74 11

– 330 57

– 9 6 37% 3%

Park model Silver Creek 224 53 33 3

– 170 29

– 39 6% 0%

Other 809 37 48 11

– 160 39

– 60 16% 0%

Mobile

home Cavalier 921 42 7 8 14

– 320 65

– 95 36% 2%

Other 4,486 27 53 11

– 120 45

– 63 4% 0%

Total 46,970 519 77 3

– 590 70

– 85 38% 5%Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 27 Table 4 . Activities Reported by Occupan ts in 519 Occupied FEMA

- Supplied Trailers in Louisiana and Mississippi, December 2007

– January 2008

Category Variable No. (%) Weighted (%)

Temperature and

v entilation No. hours air conditioning used per day in week before testing

< 1 hour 212 41 44

1

– 4 hours 136 26 27

5

– 8 hours 56 11 10

> 8 hours 82 16 13

Don’t know 33 6 6

No. hours heat used per day in 2 weeks before testing

< 1 hour 134 26 28

1

– 4 hours 154 30 29

5

– 8 hours 98 19 21

> 8 hou rs 106 20 16

Don’t know 27 5 6 Space heaters regularly used

Yes 198 38 44

No 301 58 53

Don’t know 20 4 2 Windows/doors/scuttles left open within 3 hours before testing

Yes 202 39 44

No 299 58 54

Don’t kno w 18 3 2

Time windows/doors/scuttles left open before testing

< 1 hour 171 33 37

1

– 4 hours 75 14 14

5

– 8 hours 9 2 2

> 8 hours 41 8 10

Don’t know 223 43 37 Smoking No. people who have smoked in trailer the prior 2 weeks

None 335 65 66

1 112 22 21

> 2 72 14 13

Someone smoked in the 3 hours

before testing

Yes 105 20 19

No 399 77 79

Don’t know 15 3 2 Cooking Anyone cook in trailerFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 28 Yes 410 79 81

No 82 16 15

Don ’t know 27 5 4 Anyone cook in trailer in the 3 hours before testing:

Yes 86 17 14

No 397 76 80

Don’t know 11 2 2 Question skipped 25 5 5

Time i ndoors Average amount of time per day respondent spent inside trailer

< 1 h our 0 0 0

1

– 4 hours 9 2 1

5

– 8 hours 70 13 14

> 8 hours 424 82 82

Don’t know 16 3 3 Household member sleeps in

trailer

Yes 482 93 93

No 13 3 3

Don’t know 24 5 4

Pets No. trailers with at least 1 dog 113 22 20

N o. trailers with at least 1 cat 30 6 5

N o. trailers with at least 1 bird 10 2 1

N o. trailers with other pets 11 2 1

Products u sed Pesticides sprayed in past month:

Yes 86 17 17

No 410 79 79

Don’t know 23 4 4

Candles used in th e week before testing

Yes 128 25 24

No 391 75 76

Air freshener used in week

before testing

Yes 308 59 61

No 211 41 39 Glue, paint, or furniture finish

used in week before testing

Yes 17 3 3

No 502 97 97

Mo thballs used in week before testing

Yes 5 1 1

No 514 99 99Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 29 Closet Fresh used in week before testing

Yes 5 1 1

No 514 99 99 Nail polish used in week before testing

Yes 53 10 9

No 466 90 91

Trailer c ondition Roof leak ed in the past 3 months

Yes 72 14 17

No 412 79 77

Don’t know 35 7 6 Pipe leak ed in past 3 months

Yes 70 13 15

No 427 82 81

Don’t know 22 4 4 Reported mold in past 3 months

Yes 93 18 21

N o 403 78 75

Don’t know 23 4 3Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 30 Table 5 . Walk

- T hr ough Observations by Investigators in 519 Occupied FEMA

Supplied Trailers in Louisiana and Mississippi, December 2007

– January 2008

Category Variable No. (%) Weighted (%)

Trailer c haracteristi cs Problems seen with the roof

Yes 33 6 6

No 483 93 93

Don’t know 3 1 <1 Signs that water spills onto siding

Yes 66 13 13

No 453 87 87 Signs of mold in living area of

trailer
Yes, < 1 ft 2 26 5 4
Yes, 1

– 4 ft 2 17 3 4
Yes, > 4 ft 2 11 2 2

No 465 90 90 Carpeting in trailer

Yes 191 37 43

No 328 63 57

Air c onditioning Forced air

Yes 273 53 40

No 246 47 60 Rooftop air conditioning

Yes 224 43 5 7

No 295 57 43 No working air conditioning

Yes 3 1 <1

No 516 99 99 Other type of air conditioning

Yes 7 1 <1

No 512 99 99 Heating Central heating/forced air

Yes 463 89 89

No 56 11 11 Space heater

Yes 91 18 2 1

No 428 82 79 No working heating system

Yes 2 <1 1

No 517 99 99 Other type of heating system

Yes 16 3 2

No 503 97 98Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 31 Fuel s ource for cooking E lectricity

Yes 214 41 23

No 305 59 77

P ropane gas
Yes 272 52 71

No 247 48 29

N atural gas

Yes 3 1 <1

No 516 99 99

C harcoal or wood

Yes 0 0 0

No 519 100 100

O ther

Yes 7 1 2

No 512 99 98

Smoke d etectors Functioning smoke detectors

Yes 390 75 71

No 129 25 29Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 32 Table 6

. Adjusted Geometric Mean Formaldehyde Level from Occupied FEMA

Supplied Trailers in Louisiana and Mississippi that Had Mold ( ≥ 1 ft 2 ), December

2007

– January 2008, from Multivariate Analysis

Mold > 1 ft 2 No. Trailers Adjusted G M Formaldehyde (ppb)*

Yes 2 8 86

No 491 63 *Adjusted for stratum, average temperature, relative humidity, and open

windows /doors /scuttles 3 hours before testing (all significant multivariate variables). GM=geometric mean.

Table 7

. Adjusted Geometric Mean Formaldehyde Level from Occupied FEMA

Supplied Trailers in Louisiana and Mississippi that Had Open Windows

, Doors , or Scuttles 3 Hours Before Testing, December 2007

– January 2008, from Multivariate

Model

Windows/Doors/ Scuttles Open No. Trailers Adjusted G M Formaldehyde (ppb)*

Yes 202 65

No 299 83 *Adjusted for stratum, average temperature, relative humidity, and presence of mold ( ≥ 1

ft 2 ) (all significant multivariate variables). GM=geometric mean.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 33 Table 8

. Adjusted Geometric Mean Formaldehyde Level from Occupied FEMA

Supplied Trailers in Louisiana and Mississippi

, by Strat um , December 2007

– January 2008, from Multivariate Mo del

*Adjusted for average temperature, relative humidity, windows/doors/scuttles open 3

hours before testing, and presence of mold ( ≥ 1 ft 2 ) (all significant multivariate variables). GM = geometric mean. Strat um Adjusted GM Formaldehyde Level (ppb)*

Travel trailer

Gulfstream 111 Pilgrim 129

Fleetwood CA 44

Fleetwood 4 2

Forest River 102 Keystone 1 22

Other 90

Park model

Silver Creek 37

Other 55

Mobile h ome Cavalier 84

Other 62Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 34 Table 9 . Estimated Regression Coefficients for Modeling of Statistically Significant Variables of Occupied FEMA

- Supplied Trailers in Louisiana and Mississippi,

December 2007

– January 2008

Variable Estimate P value Intercept 0.012 (α) 0. 983

Gulfstream travel trailer Reference group Pilgrim 0.148 (ß 1 ) 0. 232

Fleetwood CA

- 0.917 (ß 2 ) <0.001

Fleetwood

- 0. 965 (ß 3 ) <0.001

Forest River

- 0 .085 (ß 4 ) 0. 600 Keystone 0.096 (ß 5 ) 0. 477

Other travel trailer

- 0.215 (ß 6 ) 0. 114

Silver Creek park model

- 1.094 (ß 7 ) <0.001

Other park model

- 0.695 (ß 8 ) < 0.001

Cavalier mobile home

- 0.275 (ß 9 ) 0. 016

Other mobile home

- 0.583 (ß 10 ) <0.001 Temperature (°F) 0.052 (ß 11 ) <0.0 01 Relative humidity (%) 0.017 (ß 12 ) <0. 001

Windows/doors/scuttles open (yes) - 0.243 (ß 13 ) 0.0 17

Mold ( ≥ 1 ft 2 ) 0.311 (ß 14 ) 0.0 52 y = natural log of formaldehyde levels (ppb).

Formaldehyde Level Multivariate Model:

y = 0. 012 + 0.148 x 1 - 0.917 x 2 - 0.965 x 3 - 0.085 x 4 + 0.096 x 5 - 0.215 x 6 - 1.094 x 7 - 0.695 x 8

- 0.275 x 9 - 0.583 x 10 + 0.052 x 11 + 0.017 x 1 2 - 0.243 x 13 + 0.311 x 14Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 35 APPENDIX A:

PROTOCOL FOR TRAILER SELECTION AND RECRUITMENT

CONTACTING PARTICIPANTS: Materials needed

1. You will receive a stratified list of names and up to 3 phone numbers of residents in trailers from a CDC representative. This list represents the people whom you will contact for participation in the study.

2. For each trailer , you will need one clean phone log form (Appendix B) to log all attempted and successful calls.

3. You will need a copy of the telephone script (Appendix B ) to ensure that each

conversation is consistent.

4. You will need a clean copy of the “Obtaining Assent ” form (Appendix C) for

each trailer contacted.

CONTACTING PARTICIPANTS: Conducting the phone calls

1. You will need to make the calls from the provided s preadsheet.

2. Begin with the first name on the list and call them using the first number provided.

3. If you are unable to get an answer, try the next phone number provided.

4. After each attempt, record the information in the phone log (Appendix B).

5. Fifteen a ttempts using each provided number must be made before ending the recruitment of the person from the contact list. Over h alf of these attempts should be made after 5 pm in the event that the contacts are not at home to receive the call during the day.

6. If you are unable to contact a trailer after making fifteen attempts for each provided phone number, the majority of which attempted after 5 pm, file the recorded phone log into a folder label e d “Unable to Contact”. If you are unable to reach a contact :

If you are a ble to contact a person in the trailer

7. When someone answers the phone, use the phone script (Appendix B) to guide

the conversation. :

8. If the adult resident is not available, you will need to continue efforts to make

contact with him/her.

9. If the adult resident is NOT interested in participating, note refusal in the phone log. File the phone log into a folder labeled “Refused”.

10. If the adult resident is interested in participating, ensure that they are eligible using the criteria outlined in the p hone script.

11. If the adult resident agrees to participate, obtain verbal assent (Appendix C) and set up an appointment date and time with the adult resident.

12. Record “Agreed” in the phone log and file the phone log AND assent form in a folder labeled “Agreed ”.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 36 RECRUITMENT COMPLETION

1. Recruitment is complete when all 11 strata have been completed. This will

consist of at least 500 trailers total.

PARTICIPANT FOLLOW

- UP : Appointment reminder

1. P rior to their appointment, call the adult resident to confirm t he sampling date

and time

2. If the respondent can no longer make the appointment , reschedule the appointment.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 37 APPENDIX B:

PHONE LOG FOR PARTICIPANT RECRUITMENT

Interviewer initials

_______ Number on spreadsheet

_______________________________________ Trailer VIN

_______________________________________ Address

_______________________________________ Adult resident name

_______________________________________

Phone number (s) 1:______________________________
2:___________________________

___ 3:______________________________

In terviewer must make at least 15 attempts for each provided phone number ( of

which

, half of the attempts must be conducted in the evening , after 5 pm ) to contact each potential trailer

.

Date called (mm/dd/yy ) Time

called (am/pm) Phone

number

called (1, 2, or 3) I =For initial

contact

F =Follow

- up call

A =Name of

alternative adult

resident representative Status ( N o answer, L eft message,

C all back,

A greed,

R efused,

E xcluded) Recommended

call back time (am/p m)Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 38 APPENDIX B , con’t:

TELEPHONE SCRIPT FOR PARTICIPANT RECRUITMENT

IF CHILD ANSWERS THE PHONE :

Hi, may I speak with your mother or father please?

IF NO ADULT IS HOME:

Okay. Could you please tell me what would be a good time to call back?

[NOTE IN PHONE LOG]

Thank you, I’ll try calling back later.

IF AN ADULT ANSWERS THE PHONE :

Hello, this is ____________ calling for the Centers for Disea se Control and Prevention.

Is this the ___ (NAME) ______residence? I am working with FEMA and the Louisiana and Mississippi Departments of Public Health to find out if there is formaldehyde (a potentially harmful chemical) in the trailers in which peo ple are living. We have picked some trailers at random, like flipping a coin. May I ask if you are an adult resident living in a FEMA

- owned trailer?

IF NO Okay, we will be working with all adult residents who are 18 years or older. What is a good t ime to call back to speak with him or her? And is

this the best number to reach him/her? ,

[NOTE NAME AND TIME IN PHONE LOG]

Thank you, I’ll try calling back later.

I F YES We are asking the people who live in the trailers to let us test the ind oor air for formaldehyde. We have picked your trailer as one that we would

like to test. ,

What we learn will help the federal government make decisions about if some people need to be moved out of their trailers to protect their health. For your inconve nience, a $50 gift card will be given to you at the completion of the study. Participation is voluntary. Do you think you may be interested in participating?

IF NO Thank you. I appreciate you taking time out to talk.

IF YESFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 39 Great. I would like to first ask you a few questions about yourself

and your trailer . GO TO CRITERIA (below)

CRITERIA

1. Are you, as an adult resident, 18 years in age or older ? If YES, continue to question 2 If NO, go to “End of interview for exclusions”

2. Do yo u still live in a FEMA

- issued trailer more than 6 hours per day?
If YES, continue to next section If NO, go to “End of interview for exclusions”

IF YES is answered for questions 1

- 2:

If you agree to have us test your trailer, several things wi ll take place:

1. We will set up a time to visit your trailer soon . The visit will not

take more than an hour and a half. Cooking and smoking will not be allowed during the testing process.

2. We will ask you some questions about how you cook in your home and if people smoke in your home.

3. We will look around your home and fill out a short form about what type of heating you have, what type of stove you cook on, what type of air conditioner you have, and other similar questions.

4. We will test y our trailer for formaldehyde and will also measure the temperature and humidity. We will deliver the test results of your trailer to you about a month after we test it.

5. For your time and inconvenience, you will also receive a $50 gift

card

Are you interested in participating in this study?

IF YES

GO TO “WHEN SOMEONE AGREES TO PARTICIPATE”

IF NO Okay, thank you so much for your time.
[HANG UP AND RECORD IN PHONE LOG AS REFUSAL]

END OF INTERVIEW FOR EXCLUSIONS Thank you very much for your interest and for your willingness to be in the study. Unfortunately, it is important that people in our study be the adult resident and are 18 years or older. Also, because we are interested in the formaldehyde levels that people are

c urrently exposed to, we are working with those who are still living in their FEMA

issued trailer

. Thank you again for your time. [RECORD AS EXCLUSION IN PHONE LOG]Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 40 WHEN SOMEONE AGREES TO PARTICIPATE

Go to A ppendix C: OBTAINING ASSENT [RECORD AS AGREED IN PHONE LOG]Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 41 APPENDIX C : OBTAINING ASSENT

Thank you for helping us with this important project. Everything you tell us and all your test results will be kept private to the extent allowed by the law. To protect your privacy, we will not put your name on the project forms, but we will write down your trailer’s

address or a unique identification number assigned by the CDC.

You can change your mind and decide that you do not want us to test your trailer. If you do change your mind, it will not a ffect any of your benefits from the Federal

Government

.

____________________________________ _________ _________ Adult resident’s Name Date Time

____________________________________ _________ _________ Person Obtaining Assent Date Time

“I n my opinion, this person cannot give informed assent.”

____________________________________ _________ _________ Person conducting telephone interview Date TimeFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 42 APPENDIX D:

INFORMED CONSENT FOR PARTICIPATION

Evaluation of Formaldehyde in Occupied FEMA Owned Temporary Housing Units

For all potential participants, the informed consent document will be available for the participant to read or, if requested by the participant, will be read out loud. Participants will be required to provide a signatur e to document informed consent. The informed consent document will request permission for collection and testing of a laboratory sample

.

(Flesch

- Kincaid Reading Level for English text below = 5.2 )

1. Introduction and purpose

We are working for the Cent ers f or Disease Control and Prevention (CDC). CDC

is working with the Federal Emergency Management Agency (FEMA) to find out whether there is formaldehyde (a potentially harmful chemical) in the trailers people are living in

. We have picked some trailers at random, like flipping a coin. We are asking the people who live in those trailers to let us test their inside air for formaldehyde. We have picked your trailer as one that we would like to test.

What we learn will help CDC and FEMA make decisions on h ousing placement priorities and if some people need to be moved into different trailers to protect
their health. The testing process will include air testing which will take no more than one hour and a half. At the same time there will be a brief inspect ion of the trailer for up to 30 minutes, and some questions to be answered by you for up to

15 minutes . Section 301 of the Public Health Act permits us to collect such

information. No cooking or smoking will be allowed during the testing process.

We a re doing this testing in a scientifically valid way. That means that we choose the trailers to test instead of letting people ask to have their trailer tested. You and FEMA will learn the formaldehyde level in your trailer, and FEMA will learn

the formal dehyde levels across many other trailers. This will help FEMA make decisions to protect people’s health.

You can choose to be part of this project or not

. We will explain what we want to do to you so you can decide . Please ask us questions if you do not understand something. If you choose to be part of this project , you will need to sign this

form. Then w e will give you a copy of this form. 2. Freedom of choice

If you agree to be in this evaluation , you can learn more about your home

environment

. If the formaldehyde level in your trailer is high, you may be given priority for housing relocation. 3 . Benefits /RisksFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 43 Everything you tell us and all your test results will be kept private to the extent allowed by the law. To protect your privacy, we will not put your name on the project forms, but we will write down your trailer’s address or a unique identification number assigned by the CDC. We will tell FEMA about the levels of formaldehyde in each trailer. Personally identifying data will be destroyed by the CDC, but left at the Louisiana and Mississippi Departments of Public Health

at the completion of the study. 4 . Confidentiality

It will not cost you anything to have your trailer tested as part of this project. You

will be com pensated for your time and inconvenience with a $50 gift card at the completion of the study. 5 . Cost/Payment

Before we start, we want to make sure you understand that it is up to you whether or not to join this project

. You have the righ t to ask us to stop the testing at any time for any reason. 6 . Right to refuse or withdraw

If you have any questions please feel free to ask us now. 7 . Persons to contact

If you have questions later, please contact : Matt Murphy at 770

- 488

- 3417 or Gary Noonan at 770

- 488

- 3449

If you feel that you have been harmed by this evaluation or if you have any concerns about your rights, please contact the CDC Deputy Associate Director for

Science in Atlanta, Georgia, USA at 800

- 584

- 8814

.

I agree to allow the air in my t railer to be tested

. The information in this informed consent form has been explained to me. I have been given a chance to ask questions. I feel that all of my questions have been answered. I know that it is my choice to allow the air testing or not

. I know that if I agree to the testing I can have it stopped at any time. 8 . Your consent

I give permission for an air sample to be collected and tested for formaldehyde, and for the temperature and humidity to be measured in my home. 

### □ YES □ NO

I have read or had this form read to me. By signing below, I consent to the air testing and to providing answers to the survey questions.

_____________________________________________ ______________________ N ame and signature of particip ant Date (mm/dd/yyyy)Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 44 _____________________________________________ ______________________ N ame and signature of witness Date (mm/dd/yyyy)
Office use only

Place ID label hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 45 APPENDIX E: EXPOSURE ASSESSMENT QUESTIONNAIRE AND WALK THROUGH

SURV EY

INTERVIEWER SCRIPT :

The purpose of this part of the interview is to collect some information about you and your FEMA trailer environment. If there is a question that you do not want to answer, please let me know and we can skip it. All of your res ponses will be kept private and will not affect any of the home or health care services that you currently

receive.

This interview will begin with a few questions about your age and where you work.

We will then look at the inside and outside of your trai ler. We will walk around and through your trailer with you to make some observations. Office use only

Place ID label

hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 46 Form Approved

O MB No. 0920

- 0008

E xpiration Date 3/31/2010

EXPOSURE ASSESSMENT QUESTIONNAIRE AND

WALK THROUGH SURVEY

Date ___________________ (mm/dd/yyyy)

Interviewer initials

___________________

Trailer VIN

________________________ Trailer barcode

_________________ Trailer type: Travel trailer Mobile home Park Other

Street address:

____________________________________________________________ County:

_______________________ State (circle one): LA / MS Zip code:

_______________________

Is this home located on private land or in a federal/commercially owned park?

Private land Park If a park, please indicate the park name: _________________________

______________

Trailer occupied s ince _____

__________________ (mm/dd/yyyy)

Who pays for your utilities? Self FEMA Other

Total number of residents in trailer

_______________

Number of residents in trailer, by age group

_______________ adults ( ≥18 years)
________________children ( ≥13

- <18 yrs) ________________children (3

- <13 yrs)
________________children (<3 yrs)

May we contact you if we have any additional questions? Yes No

If YES , what is the best phone numb er to use and time of day to call?

Phone: ( ) ___________________ Time: _______

______ AM / PM

Alternate: ( ) ___________________ Time: _______

______ AM / PM

Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including Office use only

Place ID label

hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 47 sugges tions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D

- 74, Atlanta, Georgia 30333; ATTN: PRA (0920

- 0008)Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 48 Pests

1. Have pesticides been sprayed inside your home the past month ?  Yes
 No
 Don’t know

Indoor environment

2. Does your trailer have air conditioning?  Yes
 No (go to question # 4)

3. During the past 2 weeks , how many

hours

— on average

— did you keep your air conditioning running every day?  Less than 1 hour
 1

– 4 hours
 5

– 8 hours
 More than 8 hours
 Don’t know

4. During the past 2 weeks , how many

hours

— on average

— did you keep your heater running every day?  Less than 1 hour
 1

– 4 hours
 5

– 8 hours
 More than 8 hours
 Don’t know
 No working heater in trail er 5. Do you regularly use space heaters?  Yes
 No
 Don’t know

6. Were the windows, scuttles, and/or door open in the past 3 hours?  Yes
 No ( go to question # 8 )
 Don’t know

7. Approximately how long did you keep your windows and/or door

open before this visit ?  Less than 1 hour
 1

– 4 hours
 5

– 8 hours
 More than 8 hours
 Don’t know

8. Did anyone smoke in here in the past 3 hours?  Yes
 No
 Don’t know

9. During the past two weeks , how many people have smoked in here? # Peopl e:

_____________
10. How many packs of cigarettes are smoked in this house each day?  None
 < 1⁄2 pack
 1⁄2

- 1 pack
 >1

– 2 packs
 > 2 packs
 Don’t know

11. Does anyone cook in here?  Yes
 No (go to question #13) Office use only

Place ID label

here INTERVIEWER QUESTIONNAIRE Office use only

Place ID label

here Office use only

Place ID la bel

here

Office use only

Place ID label

hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 49  Don’t know

12. D id anyone cook in here the past 3

hours?  Yes
 No
 Don’t know

Daily activities

13. What is the average amount of time that you spend inside your trailer each day?  Less than one hour
 1

- 4 hours
 5

- 8 hours
 More than 8 hours
 Don’t know

14. Do you or your household members sleep in this trailer?  Yes
 No
 Don’t know

15. Were any of the following used here in the past week?  Candles
 Air fresheners
 Glue, paint, furniture finish
 Mothballs
 Closet fresh (mildewcide)
 Nail polish

16. Do you have any pets that you keep in here and how many?  Dog #:_____
 Cat #:_____
 Bird #:_____
 Other:___________ #:____

17. Have you noticed the roof leaking in the past 3 months?  Yes
 No
 Don’t know

18. Have you noticed pipes leaking in the past 3 months?  Yes
 No
 Don’t know

19. Have you noticed mold in your home during the past 3 months?  Yes
 No
 Don’t knowFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 50 Questions pertaining to the trailer (Check all that apply)

1. Do you see any problems with the roof (for example sagging or holes)?  Yes
 No
 Unable to see entire roof

2. Are there signs that water spills onto siding?  Yes
 No

3. Are there any signs of mold in the living area of the trailer?  Yes
 No

If YES , estimate size of mold growth?
 < 1 sq. foot
 1

- 4 sq. feet
 > 4 sq. feet

4. Is there carpeting in the trailer?  Yes
 No

5. What type of air conditioning doe s the trailer have?  Central AC/forced air
 AC/chiller on roof of

Trailer
 No working AC system
 Other:_________________

6. What type of heating does the trailer

have?  Central heating/forced air
 Space heaters
 No working heating system
 Other: _________________

7. What type fuels are used for cooking?  Electricity
 Propane Gas
 Natural Gas
 Charcoal or wood
 Other:

_____ 8. Is there a functioning smoke

detector?  Yes
 No

Notes:

__________________________________________________________________

________________________________________________________________________ INTERVIEWER WALK

- THRU OBSERVATION Office use only

Place ID label

hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 51 APPENDIX F :

ENVIRONMENTAL SAMPLING PROTOCOL

Formaldehyde Samples

Analysis Method :

Formald ehyde samples will be collected using the NIOSH Manual of Analytical Methods (NMAM) Method 2016 with Supelco S10 LpDNPH cartridges. The limit of detection (LOD) shall be 0.07 microgram per sample and the limit of quantification (LOQ) shall be 0.23 microgr am. Lower LOD and LOQ are acceptable. A minimum quantifiable concentration of 0.0063 parts per million is required with a 30 liter sample volume

collected over one hour. The definition from the NMAM should be used for LOD and LOQ ( http://www.cdc.gov/nio sh/nmam/pdfs/glossary.pdf ).

Sample Collection:

Samples will be collected at a flow rate of 500 ± 50 milliliters per minute for one hour. Each sample will be collected in the center of the trailer primary living room on a four

foot tall stand that mimics the breathing zone height of an adult when sitting. Residents will be asked to configure doors and windows as they would have them while they slept. Sampling will be under observation by one of the sampling team members at all times. Every tenth sample c ollected by a team will be a duplicate sample. Sampling will occur during a specific window of time per day for all trailers which is between 10:00 AM

– 8:00 PM. No cooking or smoking in the trailer will be allowed during the one

- hour sample collection p eriod.

Quality Assurance and Control:

Six to ten, or additional as required by the lab, media blanks will be taken from each lot of sample tubes. The media blanks should be taken from the start of a lot (2 to 3), from the middle of a lot (2 to 4) and f rom the end of a lot (2 to 3). All media blanks should be logged on the chain of custody sheet and sent for analysis on the day that they were collected with the field blanks and samples.

Two to ten, or additional as required by the lab, field blanks wil l be collected on each day in which samples are collected. This can be divided by travel groups, (groups consisting of teams that are operating in close proximity or who are traveling together)

. All field blanks should be logged on the chain of custody s heet a nd sent for analysis on the day that they were collected with the media blanks and samples.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 52 Sample Handling:

Sample tubes will be stored in a freezer or in a cooler on ice at all times (upon receipt, while not being used for sampling, and during shi pment to the laboratory).

At the end of each sampling day samples will be shipped to the analytical laboratory either overnight or if collected after the last overnight drop off time the next morning in coolers with chain of custody documents enclosed or attached. Samples collected on Saturday and Sunday will be stored on ice or in a freezer and shipped by overnight means with the appropriate chain of custody documents to the analytical laboratory on the following Monday morning.

Temperature and Relativ e Humidity

Temperature and relative humidity will be logged using a HOBO® brand temperature and relative humidity logging instrument manufactured by Onset Computer Corporation (or equivalent) and will be set to collect data at five minute intervals. Data will be collected during the site visits for a minimum of 5 minutes before and 5 minutes after the collection of the formaldehyde sample at each trailer . Data logs will be divided into individual logs for each sample. A suggested method for this is to fl ag the start and stop times by an event marker at the start and finish of data collection. Data will be downloaded to a laptop at end of each day. Files will be labeled with site #, date, and visit number in a standard form. Data event flags will be con firmed on the sample

collection data sheet. Files will be e

- mailed each day to the database manager.

Data Sheets

Data sheets will be filled out prior to and during site visit. Information about trailer received prior to site visit will be confirmed at time of site visit. Data sheets will be faxed or sent overnight each day to the database manager.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 53 SAMPLING STANDARD OPERATING PROCEDURE

Preparation prior to site visit:

Formaldehyde

Operational Checks:

1) Pump and calibrator batteries checked for charge a nd functionality. 2) Pump flow rates calibrated to 500 ± 50 milliliters per minute. 3) Sample tubes lot # and expiration date checked. (Expired tubes will be discarded)

4) If necessary, collect media blanks and label. 5) Stock coolers with “Blue Ice” 6) Sample tubes pla ced in cooler in number to be equal to trip blanks and samples to be

collected + 2.

Temperature and Relative Humidity

Turn on HOBO® instrument and check for proper operation

.

Operational checks:

1) Confirmation of time synchronization a) Time must agree ± 1 minute with Formaldehyde Chronometer. b) Time should be adjusted if necessary. 2) Confirm readings of HOBO® meet manufacturer’s specifications. a) Temperature readings must be ± 0.63 o C of average temperature reading of all HOBO® instruments in group. b) Humidity rea dings must be ± 2.5% of average humidity reading of all HOBO® instruments in group. c) Any HOBO® falling outside the manufacturer’s specifications will be flagged as out of calibration and removed from service until a calibration is performed. 3) Confirm that HOBO® is set to log Temperature and Humidity measurements at five

minute intervals. a) Adjust to 5 minute data logging interval if necessary. b) Confirm event marker is operating correctly. (If not remove from service)

Data Sheet

10. Confirm information is correct for scheduled site visits.

11. Confirm sheets for all scheduled site visits are present.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 54 Site Visit:

Formaldehyde

1. Calibrate pumps to a flow rate of 500 ± 50 milliliters per minute.

2. Record pump identification and pre

- sample flow rate data on data sheet.

3. Label Sample tube.

4. Sample tube and trip blank data recorded on data sheet.

5. Sample tube set on tripod at central unobstructed location in the THU at breathing

level.

6. Pump started and time recorded on data sheet.

7. Sample collected for 60 ± 2 minutes.

8. Pump st opped sample immediately capped and stop time recorded on data sheet.

9. Sample returned to cooler.

10. Pump post sample flow rate checked and recorded on data sheet.

11. Sample identification on tube confirmed with data on sample sheet.

12. Trip blanks will be recorded, processed, labeled and returned to cooler.

Temperature and Relative Humidity

1. Confirm that data logger is operating.

a. LED blinks.

2. Activate event marker at least 5 minutes prior to start of formaldehyde sample.

a. Press button for one second.

3. Record start time for HOBO® sample on data sheet.

4. Continue sampling until at least 5 minutes after completion of Formaldehyde sample, activate event marker to indicate end time of data collection.

a. Press button for one second

5. Record stop time on data sheet.

Data Shee t

1. Confirm with the occupants that information previously provided is correct

2. Completely fill out data sheet.

3. Have second team member confirm that data sheet is complete.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 55 Post Site Visit:

Formaldehyde

Monday

- Friday samples

1. Confirm that the proper n umbers of field and media blanks are enclosed.

2. Chain of custody documents completed for each sample.

3. Cooler “Blue Ice” refreshed.

4. Cooler sealed and shipping label affixed for overnight shipment to lab.

Saturday and Sunday samples

1. Confirm that the prope r numbers of field and media blanks are enclosed.

2. Chain of custody documents completed for each sample.

3. Samples stored in freezer.

Monday morning

1. Cooler “Blue Ice” refreshed.

2. Cooler sealed and shipping label affixed for overnight shipment to lab.

Tem perature and Relative Humidity

1. Data downloaded to a laptop hard drive. a. Data files will be named with Site #, date and visit number in the form

– LA

001.10

- 12

- 2007.01. (Or similar) 2. Data file event marks will be checked against data sheet start and stop times.

3. Data e

- mailed to data base manager.

Data sheet

Fax or overnight data sheet to data base manager.Final CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 56 APPENDIX G : SAMPLE DATA SHEET FOR FORMALDEHYDE, TEMPERATURE, AND

RELATIVE HUMIDITY DATA COL LECTION

Date

___________________ (mm/dd/yyyy)

Sampling Team ______________________

TRAILER INFORMATION

THU Manufacturer

________________________________________________ THU Model

________________________________________________ VIN Number

________________________________________________ Unique Trailer ID

________________________________________________ Date of Manufacture

_______________________ (mm/dd/yyyy)

THU Address

________________________________________________ THU Type Trave l trailer Mobile home Park Other

Unit Faces: N S E W (circle one)

Neighborhood North:
Residential/Office/Retail/Manufacturer/Other_____________

South:

Re sidential/Office/Retail/Manufacturer/Other_____________

East: Residential/Office/Retail/Manufacturer/Other_____________

West: Residential/Office/Retail/Manufacturer/Other_____________

Comments: Office use only

Place ID label hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 57 APPENDIX G, con’t : SAMPLE DATA SHEE T

Date

___________________ (mm/dd/yyyy)

Sampling Team ______________________

TEMPERATURE and RELATIVE HUMIDITY Sample Location

___________________________ Sampling Height (inches) ___________________________

HOBO No.

___________________________ HOBO S/N

____________________________ Start Time _____________ AM/PM Stop Time _____________ AM/PM

HOBO Data File Name

___________________________________________________

FORMALDEHYDE SAMPLE Sample Number

_____________ Tube Lot

__________________ Pump Number S/N _____________ Tube S/N

__________________
Pre

- Sample Cal ibration Flow (LPM) _________ Start Time

_________ AM/PM

Post- Sample Ca libration Flow (LPM) _________ Stop Time

_________ AM/PM

Average Flow (LPM) ______________ Sample Time (mi n)

_____________ Sample Volume (L) ______________

Field Blank S/N ______________ Chain of Custody
#_____________

Shipped via ______________ Shipping #

____________________

THU ENVIRONMENT DURING SAMPLING

Number of windows open:  0  1  2  3  4

Door open?  Yes  No  Don’t know

Air conditioning on?  Ye s  No  Don’t know

Heat on?  Yes  No  Don’t know

Exhaust hatch open?  Yes  No  Don’t know Office use only

Place ID label hereFinal CDC Findings

— Formaldehyde Levels in FEMA

- Supplied Trailers 58 Comments:

Corrections: