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**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES

> AND TOXIC SUBSTANCES

**Date:** March 27, 2008

**[MEMORANDUM]{.underline}**

**SUBJECT:** ***Formaldehyde/paraformadehyde*** - Report of the
Antimicrobials Division Toxicity Endpoint Selection Committee (ADTC).

**FROM:** Timothy F. McMahon, Ph.D., Chair, ADTC

Antimicrobials Division (7510C)

**TO:** Sharon Carlisle, Chemical Review Manager

Mark Hartman, Branch Chief

Regulatory Management Branch II

Antimicrobials Division (7510C)

And

Timothy F. McMahon, Ph.D., Risk Assessor

Antimicrobials Division (7510C)

**PC Code:** 043001; 043002

On January 29, 2008, the Antimicrobials Division\'s Toxicity Endpoint
Selection Committee (ADTC) evaluated the toxicology data base of
**formaldehyde,** and selected toxicological endpoints appropriate for
the currently registered uses of formaldehyde and paraformaldehyde. The
conclusions of this meeting are presented in this report.

> Committee Members in Attendance

Members present were: John Redden; Stephen Dapson, Ph.D.; Jonathan Chen,
Ph.D., Michelle Centra, Najm Shamim, Ph.D; Timothy F. McMahon, Ph.D.;
Roger Gardner; Jenny Tao.

**I. [INTRODUCTION]{.underline}**

Formaldehyde is used primarily as a fumigant in agricultural premises
such as poultry and swine farms and processing plants as well as in
citrus and mushroom houses. It is used as a hard surface disinfectant in
commercial premises, industrial premises and veterinary clinics.
Formaldehyde containing products are also used in oil drilling wells for
preservation of processing waters. There are no dietary uses of
formaldehyde.

Paraformaldehyde is a white crystalline solid formed by polymerization
of formaldehyde. Presently there are 2 active products under a single PC
Code 043002. Steri-Dri™Fumigant is used as a bacteriostat, fungicide,
and sanitizer in hair/beauty salons and barber shops, and Sun Pac is
used as mildewcide for closets, cupboards, dresser drawers, trunks,
suitcases, lockers, golf bags, trailers, bathroom and kitchens, and
mobile homes.

**II. [HAZARD IDENTIFICATION]{.underline}**

> **A1. [Acute Reference Dose (aRfD)]{.underline}** \[general population
> including infants and children\]

There are no expected dietary exposures to formaldehyde or
paraformaldehyde from the currently registered uses. Therefore an acute
reference dose value is not needed.

**A2. [Acute Reference Dose]{.underline} (females 13-49)**

There are no expected dietary exposures to formaldehyde or
paraformaldehyde from the currently registered uses. Therefore an acute
reference dose value is not needed.

**B. [Chronic Reference Dose]{.underline} (cPAD)**

There are no expected dietary exposures to formaldehyde or
paraformaldehyde from the currently registered uses. Therefore a chronic
reference dose value is not needed. There is an existing chronic
reference dose value in the current EPA IRIS assessment for
formaldehyde, but for registered antimicrobial uses this value is not
needed.

> **C. [Incidental Oral Exposure ]{.underline}**

The committee determined that an incidental oral endpoint was not needed
for formaldehyde. Formaldehyde is highly volatile with a low percentage
of active ingredient in those products with residential exposures
(laundry detergents, general household cleaners) and residues available
for incidental oral exposure are not expected to occur. An accidental
ingestion is considered a misuse and is not a regulatory endpoint.
Therefore, no incidental oral endpoint was selected.

**D. [Dermal Exposure ]{.underline}**

There are available studies on the dermal irritancy and dermal
sensitization potential of formaldehyde (Krivanek et al., Flyvholm et
al, 1997). These data demonstrate irritancy and sensitization potential
of formaldehyde, which is well known. However, the committee determined
that dermal endpoints are not needed for formaldehyde for the registered
antimicrobial uses. Residential uses do not involve purposeful contact
with the skin. Use in laundry detergents and household cleaners is not
expected to result in any significant dermal exposure based on the high
water solubility of formaldehyde and the volatility of the active
ingredient.

**E. [Inhalation Exposure (all durations) ]{.underline}**

The committee considered the data set forth in the 2001 ACGIH
publication on formaldehyde as relevant for selection of a non-cancer
inhalation endpoint for use in risk assessment. Inhalation is the major
route of exposure to formaldehyde and thus hazard and risk need to be
addressed from inhalation exposures.

As noted in the ACGIH document, "A TLV-Ceiling of 0.3 ppm (0.37 mg/m^3^)
is recommended for occupational exposure to formaldehyde. This value is
recommended to minimize the potential for sensory irritation, chiefly
eye and upper respiratory tract. Although the recommended TLV is
intended to protect nearly all workers, ACGIH recognizes that the value
may not safeguard that portion of the worker population (10-20%)
reported to be responsive to low ambient concentrations (\< 0.25 ppm),
of the chemical..."

Additional published literature on human exposure to formaldehyde via
inhalation (Ballarin, C. at al., Mutat. Res. 280(1), 1992;
Akbar-Khanzadeh F., Am. J. Ind. Med. 26(1), 1994; Dally, KA et al.,
Arch. Environ. Health 36(6), 1981; Alexandersson and Hedenstierna, Arch.
Environ. Health 43(3), 1988; Alexandersson and Hedenstierna, Arch.
Environ. Health 44(1), 1989) show effects of formaldehyde on pulmonary
function and irritation of the eye and nasal passages at similar
concentrations. The level of formaldehyde causing such symptoms does not
appear to vary regardless of exposure duration (i.e. hours to years).

In 2005, the Registration Division, in conjunction with the
Antimicrobials Division, issued an emergency exemption for use of
paraformaldehyde to decontaminate microbiological containment areas and
equipment. In this assessment, the NOAEL of 0.1 ppm was selected from
the epidemiology study of Horvath et al. (JAMA 259(5), 1988), who
recorded complaints of eye, nose, and throat irritation in particle
board workers at concentrations of formaldehyde from 0.4 -- 1.0 ppm.
Four additional studies were cited in the 2005 assessment as co-critical
in support of the selected NOAEL value.

For occupational exposures, the committee felt that the 0.1 ppm
inhalation endpoint was appropriate. No uncertainty factor was applied
for occupational assessments. However, for residential and children's
inhalation exposure, an uncertainty factor of 10x was applied to the 01
ppm endpoint. The common effects of formaldehyde exposure are various
symptoms as a result of irritation of the mucosa in the eyes and upper
airways. In the non-industrial indoor environment, sensory reactions are
typical effects, but there are large individual differences in the
normal population and between hyperreactive and sensitized people. Thus,
the committee concluded that in order to protect sensitive
subpopulations (children, older people and/or sensitized persons), an
extra safety factor of 10X is applied to address this concern.

**F.** **Recommendation for Aggregate Risk Assessments**

Inhalation exposures are appropriate for aggregate risk assessment.

I.  **[CLASSIFICATION OF CARCINOGENIC POTENTIAL]{.underline}**

Formaldehyde has been extensively investigated for carcinogenic
potential and several regulatory organizations including the government
of Australia and IARC have reviewed the available carcinogenicity data
in animals and humans with respect to formaldehyde. A detailed review is
not necessary here but links to the documentation are:
[www.nicnas.gov.au](http://www.nicnas.gov.au/) for the Australian
review, and <http://monographs.iarc.fr/> for the IARC publication. The
U.S. EPA National Center for Environmental Assessment (NCEA) is also in
the process of updating the carcinogenic assessment for formaldehyde.
Information from the draft document is reproduced here with permission.

The Agency is currently reevaluating the carcinogenic potential of
formaldehyde. The historical and ongoing development of an inhalation
unit risk value to assess the carcinogenic potential of formaldehyde is
briefly summarized below. Contributors to this summary included
scientists from several EPA program offices (OPP, OPPT, ORD, OAR, and
NHEERL)

-   In 1991 IRIS published a weight-of-evidence characterization for
    carcinogenicity of formaldehyde, classifying formaldehyde as a B1
    probable human carcinogen with a potency factor of 1.3 E-5 per
    (μg/m^3^) ) on the basis of squamous cell nasal tumors observed in a
    two-year study in rats (Kerns et al., 1983).

-   In 1999 the Chemical Industry Institute of Toxicology (CIIT)
    developed a health risk assessment for formaldehyde based upon the
    animal toxicology data (CIIT, 1999). This document presented the
    dose-response modeling of these data in two distinct parts: 1).
    based upon a biologically-based dose response (BBDR) model , 2)
    benchmark dose models that were based upon point of departures at
    various response levels of the tumor and precursor data. Both these
    approaches made extensive use of the available time-to-tumor and
    mechanistic information. The 1999 assessment was subsequently
    published in various articles in peer-reviewed journals (2001, 2002,
    2003, 2004).

-   In 1999, the U.S. EPA's Office of Air and Radiation and Office of
    Research and Development, in conjunction with Health Canada,
    conducted an external peer review workshop for the CIIT BDDR model
    as well as an external written peer review and public comment period
    for their assessments. While the review was largely positive on the
    overall approach in the assessment, reviewers also pointed to the
    potential for significant uncertainty due to model mis-specification
    and uncertainties in key parameters involved in the BBDR model

-   Based on the peer review of the CIIT model, OAR determined in 2004
    that the CIIT model was the most appropriate tool for risk
    assessment for formaldehyde. OAR has subsequently used the
    formaldehyde cancer potency derived using the CIIT model for a
    number of risk assessments involving formaldehyde emissions to the
    atmosphere such as the Plywood and Composite Wood Products National
    Emission Standard for Hazardous Air Pollutants (final rule 2004,
    reconsidered final rule 2006, remanded to EPA by court 2007);
    Control of Hazardous Air Pollutants from Mobile Sources (Final Rule
    2007); and Proposed Rule for National Emission Standard for
    Combustion Turbines (2004). Health Canada, Australia, the World
    Health Organization, and the German MAK Commission have also used
    the CIIT model. Model strengths include consideration of the mode of
    action data for formaldehyde and a conservative approach to account
    for potential direct DNA interaction and mutation induction.  Model
    uncertainties include variability for some of the parameters of the
    model (e.g., cell proliferation) which can affect predictions of
    risk (Subramanian et al 2007; 2008 \[in press\]).

-   In 2004, NCEA convened a panel of experts, including scientists from
    CIIT, to provide advice on these and other critical biological and
    statistical uncertainties. The strength of the CIIT model is its
    consideration of mode of action and extensive mechanistic
    information.

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-   Although current OAR assessments still use the CIIT model, these
    assessments now acknowledge previously unknown uncertainties with
    the CIIT model when characterizing the risk results.

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-   In 2004, the International Agency for Research on Cancer (IARC)
    characterized formaldehyde as a human carcinogen based on their
    review of the current literature (IARC, 2004), including data in
    humans on nasopharyngeal cancer, cancer of the nasal cavity and
    paranasal sinuses,and leukemia. It should be noted that some
    epidemiology studies did not find a reported association between
    formaldehyde exposure and carcinogenicity. For example, Coggon et
    al, 2003 studied over 14,000 workers exposed to formaldehyde in
    industrial workplaces and reported no excesses of either leukemia or
    nasal and nasopharyngeal cancer.

-   In 2005, the Scientific Review Panel (SRP) of the California Office
    of Environmental Health Hazard Assessment responded to the CA Air
    Resources Board request to reevaluate the carcinogenic potential of
    formaldehyde. The Panel noted in this 2005 review that OEHHA's
    November 2002 evaluation of a petition had included the 1999 report
    on the CIIT model and other information, and that California's OEHHA
    had concluded that "*the evidence...(1) did not change the
    determination that formaldehyde is a carcinogen; (2) presented
    information that considered the possibility of non-linear dose
    response relationships, but presented no clear grounds to review the
    original "no threshold" determination; and (3) did not provide any
    new epidemiology or bioassays supporting a change in potency. In
    addition, there was insufficient information to fully evaluate the
    CIIT model, issues such as model uncertainty were not adequately
    addressed....*" The Scientific Review Panel's overall conclusion in
    2005 was, *"The Panel concluded that there was not sufficient new
    data to support the petition to review the \[OEHHA's earlier 1992\]
    formaldehyde risk assessment. In addition, the newly published
    studies represented relevant new information, but they did not allow
    determination of a causal relationship between formaldehyde exposure
    and leukemia. These studies deserve further evaluation over time
    given their potential importance."* Froines (2005).

-   EPA is currently completing a new IRIS assessment and unit risk
    value for formaldehyde; the reassessment is scheduled to start
    internal peer review in May 2008 and begin independent external peer
    review in January 2009
    (http://cfpub.epa.gov/ncea/iristrac/index.cfm?fuseaction=viewChemical.showChemical&sw_id=1031).
    EPA anticipates that the peer review of the formaldehyde assessment
    will be a longer process then that of EPA's reregistration process
    scheduled to conclude in September 2008.

Based of the on going development of the science to predict carcinogenic
potential of formaldehyde, OPP has decided to present the formaldehyde
cancer risks for the pesticidal uses using both the existing 1991 IRIS
cancer unit risk of 1.3 E-5 per (µg/m^3^) and the CIIT BBDR model until
any new cancer estimates are fully peer reviewed. OPP also acknowledges
the wide range in cancer risks using these approaches and will
coordinate with other offices in EPA on the outcome of the upcoming peer
review process on the carcinogenicity of formaldehyde. Because
formaldehyde air concentrations approach those associated with ocular
and respiratory tract irritation, the risk mitigation measures to be
implemented in the meantime for the pesticidal uses will be based on
mitigating the non-cancer effects at a limit of 0.01 ppm. It is believed
that this level will reduce exposures sufficiently such that the cancer
risks would not be of concern. The EPA process of regulating pesticides
allows for reevaluation at any time if new information from the peer
review process of the carcinogenic potential of formaldehyde warrants.

II. **[MUTAGENICITY]{.underline}**

Formaldehyde's mutagenicity has been examined in a variety of in vitro
and in vivo test systems. In a bacterial reverse mutation test (MRID
00132156), formaldehyde (2%) was tested at concentrations of 0.001,
0.01, 0.10, 1.0, or 5.0 µL and found to be negative. In a second
submitted study (MRID 00132157), formaldehyde (2%) was tested at
concentrations of 3.0, 15.0, 75.0, 150, or 300 µg/plate and found to be
positive in the bacterial reverse mutation assay. Formaldehyde caused a
positive response (3.2-fold increase) on tester strain TA98 without
metabolic activation. A 1.9-fold increase was observed on TA98 with
metabolic activation. Also, increases of 2.2-fold and 1.7-fold were
observed on tester strain TA100 with and without activation,
respectively. In an in vitro mammalian chromosome aberration test (MRID
00132168), formaldehyde (37% formalin), was tested on Chinese hamster
ovary cells at concentrations of 28.43, 37.91, or 50.55 nL/mL. The test
article caused a significant dose-dependant increase in the frequencies
of chromosome aberrations in the Chinese Hamster Ovary cells, both with
and without S-9 activation. One submitted study (MRID 00132169), tested
formaldehyde (37%) for Unscheduled DNA synthesis (UDS) in Primary rat
liver hepatocytes. The test material was tested at concentrations of
0.0005, 0.001, 0.005, 0.01, 0.02, or 0.04 µL/mL and found to cause no
significant increase in UDS in rat hepatocytes.

In published studies, formaldehyde has shown both positive and negative
results in the Ames Salmonella assay (Donovan et al., 1983; Connor et
al., 1983, 1985; Frei et al., 1984; Fiddler et al., 1984; Oerstavik and
Hongslo, 1985; Takahashi et al., 1985; Schmid et al., 1986; Zielenska
and Guttenplan, 1988; Le Curieux et al., 1993; O'Donovan and Mee (1993)
Watanabe et al., 1996; Dillon et al., 1998; Ryden et al., 2000; Wilcox
et al., 1990; Jung et al., 1992; Marnett et al., 1985; Mueller et al.,
1993).

Temcharoen and Thilly (1983) examined the capacity of formaldehyde to
induce forward mutations to 8-azaguanine resistance in S. typhimurium TM
677, a his^+^ revertant of TA 1535. Both toxicity and mutagenicity were
obtained at formaldehyde concentrations of 0.17 mM in the absence of S9
and 0.33 mM in the presence of S9 Dillon et al. (1998) employed
Salmonella strains TA102 and TA104 because they are more sensitive to
oxidative mutagens. Formaldehyde was mutagenic in both strains, as well
as in TA100. However, the authors reported that the mutagenic activity
was not reduced in TA104 in the presence of S9 from either
Aroclor-induced male Fischer F 344 rats or male B6C3F~1~ mice.

In another study, formaldehyde induced forward mutations to
trifluorothymidine resistance in mouse lymphoma L5178Y tk^+/-^ cells
both in the absence and presence of rat liver S9 (higher concentrations
required for effect with S9). Both toxicity and mutagenicity were
abolished when formaldehyde dehydrogenase was incorporated in the
exposure medium (Blackburn et al., 1991).

Ross and Shipley (1980) used a \[^14^C\]-thymidine-incorporated mouse
L1210 cell line to monitor formaldehyde-induced DNA strand breaks and
DPX. Single strand breaks (SSB) and DNA-protein cross links were induced
by formaldehyde, with SSB at concentrations greater than 200 M and a
reduction of radiation-induced breaks (indirect measure of DPX) at 50
M. Formaldehyde-induced DPX were repaired 24 hours after the compound
was removed from the culture.

In vivo, no treatment-related increase in either micronuclei or
chromosome aberrations were observed following intraperitoneal exposure
to formaldehyde at 0, 6.25, 12.5, or 25 mg/kg. (Natarajan et al. (1983)
). Similarly, chromosomal analysis of spermatocytes at metaphase I did
not reveal any chromosomal lesions in Q strain mice injected
intraperitoneally with 50 mg/kg of the compound (Fontignie-Houbrechts,
1981). Exposure of male and female Fischer F-344 rats to 0.5, 6, or 15
ppm (0.6, 7.4, 18.5 mg/m^3^) formaldehyde by inhalation for 6 hours/day
for 5 days showed no increases in either SCE or chromosome aberrations
at any dose level (Kligerman et al. (1984) ) .

III. **[FQPA CONSIDERATIONS]{.underline}**

There are no tolerances for formaldehyde or paraformaldehyde and the use
patterns considered for the reregistration eligibility decision do not
involve dietary exposure. As a result, a FQPA safety finding is not
applicable.

IV. **[DATA GAPS / REQUIREMENTS]{.underline}**

> There are no acceptable repeat dose dermal toxicity studies for
> formaldehyde. Although currently there are no dermal endpoints
> selected, a dermal toxicity study is considered a data gap with
> respect to the dermal concentration of formaldehyde that causes
> systemic effects and whether any systemic effects are precluded by the
> irritancy and/or sensitization potential of the chemical.

**VII. [ACUTE TOXICITY]{.underline}**

+--------+-----------------------+---------+----------------+--------+
| *      |                       |         |                |        |
| *Acute |                       |         |                |        |
| To     |                       |         |                |        |
| xicity |                       |         |                |        |
| data   |                       |         |                |        |
| for    |                       |         |                |        |
| Formal |                       |         |                |        |
| dehyde |                       |         |                |        |
| tec    |                       |         |                |        |
| hnical |                       |         |                |        |
| a.i.** |                       |         |                |        |
+========+=======================+=========+================+========+
| **Gui  | **Study Type/ Test    | *       | **Results**    | **To   |
| deline | substance (% a.i.)**  | *MRID** |                | xicity |
| Nu     |                       |         |                | Cate   |
| mber** |                       | **      |                | gory** |
|        |                       | Number/ |                |        |
|        |                       | Cit     |                |        |
|        |                       | ation** |                |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Acute Oral -- Guinea  | 0       | LD~50~ = 260   | II     |
| 0.1100 | Pig                   | 0058054 | mg/kg          |        |
|        |                       |         |                |        |
| (      | Purity 37.3% -        |         |                |        |
| §81-1) | Formaldehyde          |         |                |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Acute Dermal -- Rat   | 0       | []{.mark}      | II     |
| 0.1200 |                       | 0058054 |                |        |
|        | Purity 37.3% -        |         | Number range   |        |
| (      | Formaldehyde          |         | CHAPTERLD~50~  |        |
| §81-2) |                       |         | = 300 mg/kg    |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Acute Dermal --       | 0       | []{.mark}      | II     |
| 0.1200 | Rabbit                | 0058054 |                |        |
|        |                       |         | Number range   |        |
| (      | Purity 37.3% -        |         | CHAPTERLD~50~  |        |
| §81-2) | Formaldehyde          |         | = 240 mg/kg    |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Acute Dermal -- Dog   | 0       | Number range   | II     |
| 0.1200 |                       | 0058054 | CHAPTERLD~50~  |        |
|        | Purity 37.3% -        |         | = 550 mg/kg    |        |
| (      | Formaldehyde          |         |                |        |
| §81-2) |                       |         |                |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Acute Inhalation --   | See     |                |        |
| 0.1300 | Mouse and Rat         | Open    |                |        |
|        |                       | Lit     |                |        |
| (      |                       | erature |                |        |
| §81-3) |                       | studies |                |        |
|        |                       | in      |                |        |
|        |                       | T       |                |        |
|        |                       | oxicity |                |        |
|        |                       | Profile |                |        |
|        |                       | for     |                |        |
|        |                       | Forma   |                |        |
|        |                       | ldehyde |                |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Primary Eye           | 0       | Severe eye     | I      |
| 0.2400 | Irritation -          | 0058054 | irritant       |        |
|        |                       |         |                |        |
| (      | Purity 37.3% -        |         |                |        |
| §81-4) | Formaldehyde          |         |                |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Primary Dermal        | 0       | Formation of   | I      |
| 0.2500 | Irritation            | 0058054 | vesicles with  |        |
|        |                       |         | superficial    |        |
| (      | Purity 37.3% -        |         | necrosis or    |        |
| §81-5) | Formaldehyde          |         | nodules.       |        |
+--------+-----------------------+---------+----------------+--------+
| 87     | Dermal Sensitization  | 4       | Extreme        | NA     |
| 0.2600 | -- Guinea pigs        | 0161103 | Sensitizer     |        |
|        |                       |         |                |        |
| (      | Purity 40.0% -        |         |                |        |
| §81-6) | Formaldehyde          |         |                |        |
+--------+-----------------------+---------+----------------+--------+

**VIII. [Number range CHAPTERSUMMARY OF TOXICOLOGY ENDPOINT SELECTION
FOR OF FORMALDEHYDE]{.underline}**

+----------+-------------+---+---------------+-------------------------+
| Number   | **Dose Used |   | **Target MOE, | **Study and             |
| range    | in Risk     |   | UF,**         | Toxicological Effects** |
| CHA      | A           |   |               |                         |
| PTER**Ex | ssessment** |   | **Special     |                         |
| posure** |             |   | FQPA SF\* for |                         |
|          | **(m        |   | Risk          |                         |
| **Sc     | g/kg/day)** |   | Assessment**  |                         |
| enario** |             |   |               |                         |
+==========+=============+===+===============+=========================+
| *        |             |   |               |                         |
| *Dietary |             |   |               |                         |
| Risk     |             |   |               |                         |
| Asses    |             |   |               |                         |
| sments** |             |   |               |                         |
+----------+-------------+---+---------------+-------------------------+
| **Acute  | An acute    |   |               |                         |
| D        | dietary     |   |               |                         |
| ietary** | assessment  |   |               |                         |
|          | is not      |   |               |                         |
| (general | needed for  |   |               |                         |
| po       | the         |   |               |                         |
| pulation | registered  |   |               |                         |
| i        | an          |   |               |                         |
| ncluding | timicrobial |   |               |                         |
| infants  | uses of     |   |               |                         |
| and      | fo          |   |               |                         |
| c        | rmaldehyde. |   |               |                         |
| hildren) |             |   |               |                         |
+----------+-------------+---+---------------+-------------------------+
| *        | A chronic   |   |               |                         |
| *Chronic | dietary     |   |               |                         |
| D        | assessment  |   |               |                         |
| ietary** | is not      |   |               |                         |
|          | needed for  |   |               |                         |
| (all     | the         |   |               |                         |
| popu     | registered  |   |               |                         |
| lations) | an          |   |               |                         |
|          | timicrobial |   |               |                         |
|          | uses of     |   |               |                         |
|          | fo          |   |               |                         |
|          | rmaldehyde. |   |               |                         |
+----------+-------------+---+---------------+-------------------------+
| **Non    |             |   |               |                         |
| -Dietary |             |   |               |                         |
| Risk     |             |   |               |                         |
| Asses    |             |   |               |                         |
| sments** |             |   |               |                         |
+----------+-------------+---+---------------+-------------------------+
| **In     | An          |   |               |                         |
| cidental | incidental  |   |               |                         |
| Oral**   | oral risk   |   |               |                         |
|          | assessment  |   |               |                         |
|          | is not      |   |               |                         |
|          | required    |   |               |                         |
|          | for the     |   |               |                         |
|          | registered  |   |               |                         |
|          | an          |   |               |                         |
|          | timicrobial |   |               |                         |
|          | uses of     |   |               |                         |
|          | fo          |   |               |                         |
|          | rmaldehyde. |   |               |                         |
+----------+-------------+---+---------------+-------------------------+
| **       | A dermal    |   |               |                         |
| Dermal** | risk        |   |               |                         |
| (all     | assessment  |   |               |                         |
| du       | is not      |   |               |                         |
| rations) | required    |   |               |                         |
|          | for the     |   |               |                         |
|          | registered  |   |               |                         |
|          | an          |   |               |                         |
|          | timicrobial |   |               |                         |
|          | uses of     |   |               |                         |
|          | fo          |   |               |                         |
|          | rmaldehyde. |   |               |                         |
+----------+-------------+---+---------------+-------------------------+
| **Inha   | **NOAEL**   | * |               | ACGIH 2001 publication  |
| lation** | (human) =   | * |               | on formaldehyde         |
|          | 0.1 ppm     | U |               |                         |
| (all     |             | F |               | Horvath, E.P. et al.    |
| du       |             | = |               | (1986): JAMA 259(5):    |
| rations) |             | 1 |               | 701-707. Based on       |
|          |             | ( |               | complaints of eye,      |
|          |             | o |               | nose, and throat        |
|          |             | c |               | irritation in particle  |
|          |             | c |               | board workers at        |
|          |             | u |               | concentrations of       |
|          |             | p |               | formaldehyde from 0.4   |
|          |             | a |               | -- 1.0 ppm.             |
|          |             | t |               |                         |
|          |             | i |               | Redden, J. (2005):      |
|          |             | o |               | Section 18 Emergency    |
|          |             | n |               | Exemption for the use   |
|          |             | a |               | of Paraformaldehyde:    |
|          |             | l |               | U.S. Army Medical       |
|          |             | ) |               | Research Institute of   |
|          |             | * |               | Infectious Diseases.    |
|          |             | * |               |                         |
|          |             |   |               |                         |
|          |             | * |               |                         |
|          |             | * |               |                         |
|          |             | U |               |                         |
|          |             | F |               |                         |
|          |             | = |               |                         |
|          |             | 1 |               |                         |
|          |             | 0 |               |                         |
|          |             | ( |               |                         |
|          |             | r |               |                         |
|          |             | e |               |                         |
|          |             | s |               |                         |
|          |             | i |               |                         |
|          |             | d |               |                         |
|          |             | e |               |                         |
|          |             | n |               |                         |
|          |             | t |               |                         |
|          |             | i |               |                         |
|          |             | a |               |                         |
|          |             | l |               |                         |
|          |             | ) |               |                         |
|          |             | * |               |                         |
|          |             | * |               |                         |
+----------+-------------+---+---------------+-------------------------+
| Cancer   | F           |   |               |                         |
|          | ormaldehyde |   |               |                         |
|          | is          |   |               |                         |
|          | currently   |   |               |                         |
|          | classified  |   |               |                         |
|          | as a B1     |   |               |                         |
|          | (probable   |   |               |                         |
|          | human       |   |               |                         |
|          | carcinogen) |   |               |                         |
|          | in EPA's    |   |               |                         |
|          | IRIS        |   |               |                         |
|          | assessment. |   |               |                         |
|          | IARC has    |   |               |                         |
|          | classified  |   |               |                         |
|          | f           |   |               |                         |
|          | ormaldehyde |   |               |                         |
|          | as          |   |               |                         |
|          | "c          |   |               |                         |
|          | arcinogenic |   |               |                         |
|          | to humans." |   |               |                         |
|          | The Agency  |   |               |                         |
|          | has decided |   |               |                         |
|          | to present  |   |               |                         |
|          | the         |   |               |                         |
|          | f           |   |               |                         |
|          | ormaldehyde |   |               |                         |
|          | cancer      |   |               |                         |
|          | risks for   |   |               |                         |
|          | the         |   |               |                         |
|          | pesticidal  |   |               |                         |
|          | uses using  |   |               |                         |
|          | both the    |   |               |                         |
|          | existing    |   |               |                         |
|          | 1991 IRIS   |   |               |                         |
|          | cancer unit |   |               |                         |
|          | risk of 1.3 |   |               |                         |
|          | E-5 per     |   |               |                         |
|          | (µg/m^3^)   |   |               |                         |
|          | and the     |   |               |                         |
|          | CIIT BBDR   |   |               |                         |
|          | model until |   |               |                         |
|          | any new     |   |               |                         |
|          | cancer      |   |               |                         |
|          | estimates   |   |               |                         |
|          | are fully   |   |               |                         |
|          | peer        |   |               |                         |
|          | reviewed    |   |               |                         |
+----------+-------------+---+---------------+-------------------------+