US Environmental Protection Agency

Office of Pesticide Programs

June 2008

Reregistration Eligibility Decision for 

Formaldehyde and Paraformaldehyde
United States Prevention, Pesticides EPA 739-R-08-004 

Environmental Protection and Toxic Substances June 2008 

Agency (7510P) 

Reregistration Eligibility Decision for 

Formaldehyde and Paraformaldehyde 

(Case 0556)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

CERTIFIED MAIL 

Dear Registrant: 

This is to inform you that the Environmental Protection Agency (hereafter referred to as 

EPA or the Agency) has completed its review of the available data and public comments 

received related to the preliminary risk assessments for the antimicrobial formaldehyde and 

paraformaldehyde. The enclosed Reregistration Eligibility Decision (RED) document was 

approved on June 30, 2008. 

Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED) 

and risk management decision for formaldehyde and paraformaldehyde and their associated 

human health and environmental risks. A Notice of Availability will be published in the Federal 

Register announcing the publication of the RED. 

The RED and supporting risk assessments for formaldehyde and paraformaldehyde are 

available to the public on EPA’s Pesticide Docket at: www.regulations.gov. The docket number 

is EPA-HQ-OPP-2008-0121. 

The formaldehyde and paraformaldehyde RED was developed through EPA’s public 

participation process, published in the Federal Register on September 10, 2004, which provides 

opportunities for public involvement in the Agency’s pesticide tolerance reassessment and 

reregistration programs. Developed in partnership with USDA and with input from EPA’s 

advisory committees and others, the public participation process encourages robust public 

involvement starting early and continuing throughout the pesticide risk assessment and risk 

mitigation decision making process. The public participation process encompasses full, 

modified, and streamlined versions that enable the Agency to tailor the level of review to the 

level of refinement of the risk assessments, as well as to the amount of use, risk, public concern, 

and complexity associated with each pesticide. Using the public participation process, EPA is 

attaining its strong commitment to both involve the public and meet statutory deadlines. 

Please note that the formaldehyde and paraformaldehyde risk assessment and the attached 

RED document concern only these particular pesticides. This RED presents the Agency’s 

conclusions on the dietary, drinking water, occupational, residential and ecological risks posed 

by exposure to formaldehyde and paraformaldehyde alone. This document also identifies both 

generic and product-specific data that the Agency intends to require in Data Call-Ins (DCIs). 

Note that DCIs, with all pertinent instructions, will be sent to registrants at a later date. 

Additionally, for product-specific DCIs, the first set of required responses will be due 90 days 


Table of Contents 

Formaldehy de and Paraformaldehyde Reregistration Team ........................ i 

Glossary of Terms and Abbreviations..................................................... ii 

Abstract................................................................................................ iv 

I. Introduction................................................................................... 1 

II. Chemical Overview 

A. Regulatory History.............................................................. ... 3 

B. Chemical Identification ......................................................... 3 

C. U seProfile....................................................................................... 6 

III. Summary of Formaldehyde and Paraformaldehyde Risk Assessments 

A. Human Health Risk Assessment................................................ 10 

1. Toxicity of Formaldehyde and Paraformaldehyde ............... 10 

a. Acute Toxicity ................................................... 10 

b. Toxicological Endpoints ....................................... 11 

c. Carcinogenicity ................................................ 14 

2. FQPA Safety Factor...................................................... 16 

3. Dietary and Drinking Water Risk ..................................... 16 

4. Residential Exposure and Risk ........................................ 16 

 a. Formaldehyde Residential Handler Risk.................... 17 

 b. Formaldehyde Residential Post application Risk......... 18 

c. Paraformaldehyde Residential Handler Risk ............ 19 

d. Paraformaldehyde Post Application Residential Risk ... 19 

5. Aggr egate Risk............................................................. 19 

6. Occupational Exposure and Risk....................................... 19 

a. Occupational Handler Exposure and Risk ................. 19 

b. Occupational Post-Application Exposure and Risk ..... 20 

7. Hum a n Inc ident Data.................................................... 20 

B. Environmental Risk Assessment................................................ 22 

1. Environmental Fate and Transport.................................... 22 

2. Ecological Hazard .................................................... 23 

3. Risk to Listed Species.................................................... 23 

IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 

A. D ete r mina tion of Reregistration Eligibility.................................. 25 

B. Public Comments and Responses... ........................................... 25 

C. Regulatory Rationale.............................................................. 26 

1. Human Health Risk Management..................................... 26 

 a. Residential Risk Mitigation for Formaldehyde ............ 26 

 b. Occupational Risk Mitigation for Formaldehyde ......... 26 

c. Occupational and Residential Risk Mitigation for 27 

Paraformaldehyde 

2. Other Labeling Requirements........................................... 27 

V. What Registrants Need to Do............................................................ 28 
 A. Manufacturing-Use Products................................................... 30 

1. Additional Generic Data Requirements.............................. 30 

2. Labeling for Technical and Manufacturing-Use Products........ 30 

B. E nd-Use Products.................................................................. 30 

1. Additional Product-Specific Data Requirements..................... 30 

2. Labeling for End-Use Products ........................................... 30 

a. Label Changes Summary Table................................ 31 

VI. Ap p endic es.................................................................................. 35

A. Table of Use Patterns Formaldehyde .......................................... 36 

A.1 Table of Use Patterns ParaFormaldehyde .................................. 42 

B. Table of Generic Data Requirements and Studies Used to Make the 

Reregistration Decision............................................................... 44 

C. Technical Support Documents.................................................. 48 

D. Bib liography Citations............................................................ 50

E. Generic Data Call-In.............................................................. 70 

F. Product Specific Data Call-In...... ............................................. 71 

G. Batching of End-Use Products.................................................. 72 

H. List of All Registrants Sent the Data Call-In................................. 73

I. List of Available Forms............................................................ 74 
Formaldehyde and Paraformaldehyde Reregistration Team 

Health Effects Risk Assessment 

Timothy F. McMahon 

Jonathan Chen 

Srivivas Gowda 

A. Najm Shamim 

Timothy C. Dole 

Timothy Leighton 

Ecological Risk Assessment 

Richard C. Petrie 

Environmental Fate Risk Assessment 

A. Najm Shamim 

Registration Support 

Marshall Swindell 

Risk Management 

ShaRon Carlisle 

Diane Isbell 

i 
GLOSSARY OF TERMS AND ABBREVIATIONS 

a.i. Active Ingredient 

aPAD Acute Population Adjusted Dose 

APHIS Animal and Plant Health Inspection Service 

ARTF Agricultural Re-entry Task Force 

BCF Bioconcentration Factor 

CDC Centers for Disease Control 

CDPR California Department of Pesticide Regulation 

CFR Code of Federal Regulations 

ChEI Cholinesterase Inhibition 

CMBS Carbamate Market Basket Survey 

cPAD Chronic Population Adjusted Dose 

CSFII USDA Continuing Surveys for Food Intake by Individuals 

CWS Community Water System 

DCI Data Call-In 

DEEM Dietary Exposure Evaluation Model 

DL Double layer clothing {i.e., coveralls over SL} 

DWLOC Drinking Water Level of Comparison 

EC Emulsifiable Concentrate Formulation 

EDSP Endocrine Disruptor Screening Program 

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee 

EEC Estimated Environmental Concentration. The estimated pesticide concentration in an 

environment, such as a terrestrial ecosystem. 

EP End-Use Product 

EPA U.S. Environmental Protection Agency 

EXAMS Tier II Surface Water Computer Model 

FDA Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FOB Functional Observation Battery 

FQPA Food Quality Protection Act 

FR Federal Register 

GL With gloves 

GPS Global Positioning System 

HIARC Hazard Identification Assessment Review Committee 

IDFS Incident Data System 

IGR Insect Growth Regulator 

IPM Integrated Pest Management 

RED Reregistration Eligibility Decision 

LADD Lifetime Average Daily Dose 

LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause 

death in 50% of test animals, usually expressed as the weight of substance per weight or volume 

of water, air or feed, e.g., mg/l, mg/kg or ppm. 

LCO Lawn Care Operator 

LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals 

when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of 

substance per unit weight of animal, e.g., mg/kg. 

LOAEC Lowest Observed Adverse Effect Concentration 

LOAEL Lowest Observed Adverse Effect Level 

LOC Level of Concern 

LOEC Lowest Observed Effect Concentration 

mg/kg/day Milligram Per Kilogram Per Day 

MOE Margin of Exposure 

MP Manufacturing-Use Product 

ii 
MRID Master Record Identification (number). EPA’s system of recording and tracking studies 

submitted. 

MRL Maximum Residue Level 

N/A Not Applicable 

NASS National Agricultural Statistical Service 

NAWQA USGS National Water Quality Assessment 

NG No Gloves 

NMFS National Marine Fisheries Service 

NOAEC No Observed Adverse Effect Concentration 

NOAEL No Observed Adverse Effect Level 

NPIC National Pesticide Information Center 

NR No respirator 

OP Organophosphorus 

OPP EPA Office of Pesticide Programs 

ORETF Outdoor Residential Exposure Task Force 

PAD Population Adjusted Dose 

PCA Percent Crop Area 

PDCI Product Specific Data Call-In 

PDP USDA Pesticide Data Program 

PF10 Protections factor 10 respirator 

PF5 Protection factor 5 respirator 

PHED Pesticide Handler’s Exposure Data 

PHI Pre-harvest Interval 

ppb Parts Per Billion 

PPE Personal Protective Equipment 

PRZM Pesticide Root Zone Model 

RBC Red Blood Cell 

RED Reregistration Eligibility Decision 

REI Restricted Entry Interval 

RfD Reference Dose 

RPA Reasonable and Prudent Alternatives 

RPM Reasonable and Prudent Measures 

RQ Risk Quotient 

RTU (Ready-to-use) 

RUP Restricted Use Pesticide 

SCI-GROW Tier I Ground Water Computer Model 

SF Safety Factor 

SL Single layer clothing 

SLN Special Local Need (Registrations Under Section 24C of FIFRA) 

STORET Storage and Retrieval 

TEP Typical End-Use Product 

TGAI Technical Grade Active Ingredient 

TRAC Tolerance Reassessment Advisory Committee 

TTRS Transferable Turf Residues 

UF Uncertainty Factor 

USDA United States Department of Agriculture 

USFWS United States Fish and Wildlife Service 

USGS United States Geological Survey 

WPS Worker Protection Standard 

iii 
Abstract 

The Environmental Protection Agency (EPA or the Agency) has completed the human 

health and environmental risk assessments for formaldehyde and paraformaldehyde and is 

issuing its risk management decision. The risk assessments, which are summarized below, are 

based on the review of the required target database supporting the use patterns of currently 

registered products and additional information received through the public docket. After 

considering the risks identified in the revised risk assessments, comments received, and 

mitigation suggestions from interested parties, the Agency developed its risk management 

decision for uses of formaldehyde and paraformaldehyde that pose risks of concern. As a result 

of this review, EPA has determined that formaldehyde and paraformaldehyde containing 

products are eligible for reregistration, provided that risk mitigation measures are adopted and 

labels are amended accordingly. That decision is discussed fully in this document. 

iv 
I. Introduction

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended 

in 1988 to accelerate the reregistration of products with active ingredients registered prior 

to November 1, 1984 and amended again by the Pesticide Registration Improvement Act 

of 2003 to set time frames for the issuance of Reregistration Eligibility Decisions. The 

amended Act calls for the development and submission of data to support the 

reregistration of an active ingredient, as well as a review of all submitted data by the U.S. 

Environmental Protection Agency (EPA or the Agency). Reregistration involves a 

thorough review of the scientific database underlying a pesticide’s registration. The 

purpose of the Agency’s review is to reassess the potential hazards arising from the 

currently registered uses of the pesticide; to determine the need for additional data on 

health and environmental effects; and to determine whether or not the pesticide meets the 

“no unreasonable adverse effects” criteria of FIFRA. 

This document presents the Agency’s revised human health and ecological risk 

assessments and the Reregistration Eligibility Decision (RED) for formaldehyde and 

paraformaldehyde. The formaldehyde and paraformaldehyde case consists of one PC 

code each: 043001 (formaldehyde), 043002 (paraformaldehyde). The first product 

containing formaldehyde was registered in 1967. 

Formaldehyde as an antimicrobial pesticide is used 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 also 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. Formaldehyde is also 

registered as a materials preservative for consumer products such as laundry detergents, 

general purpose cleaners and wall paper adhesives. Paraformaldehyde is used for indrawer fumigation of hair cutting equipment and as a mildewcide in closets and 

unoccupied vacation homes. The currently registered formaldehyde products are 

formulated as liquid concentrates or liquid ready to use solutions with formaldehyde 

concentrations that range from 2.28% to 54%. The paraformaldehyde products are 

formulated as solids with paraformaldehyde concentrations of 62.3% and 91%.This 

suggests there are only 2 formulations. Just want to ensure this is not a range. 

The Agency has determined that analysis of the potential need for a special 

hazard-based safety factor under the FQPA is not needed at this time. The Agency does 

not anticipate dietary or drinking water exposures based on the registered use patterns 

and there are no tolerances or tolerance exemptions for the use of formaldehyde and 

paraformaldehyde as an active ingredient. Therefore, a FQPA hazard analysis is not 

necessary at this time. 

This document presents the Agency’s decision regarding the reregistration 

eligibility of the registered uses of formaldehyde and paraformaldehyde. In an effort to 

simplify the RED, the information presented herein is summarized from more detailed

information which can be found in the technical supporting documents for formaldehyde 

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and paraformaldehyde referenced in this RED. The revised risk assessments and related 

addenda are not included in this document, but are available in the Public Docket at 

www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121). 

This document consists of six sections. Section I is the Introduction. Section II 

provides a chemical overview, a profile of the use and usage of formaldehyde and 

paraformaldehyde and its regulatory history. Section III, Summary of Formaldehyde and 

Paraformaldehyde Risk Assessments, gives an overview of the human health and 

environmental assessments, based on the data available to the Agency. Section IV, Risk 

Management and Reregistration, presents the reregistration eligibility and risk 

management decisions. Section V, What Registrants Need to Do, summarizes the 

necessary label changes based on the risk mitigation measures outlined in Section IV. 

Finally, the Appendices list all use patterns eligible for reregistration, bibliographic 

information, related documents and how to access them, and Data Call-In (DCI) 

information. 

2 of 87 
II. Chemical Overview

A. Regulatory History

Formaldehyde

The first product containing formaldehyde was registered in the United States on 

January 25, 1967, for use as a fumigant. Currently there are 6 active products under PC Code 

043001. There are no inert ingredient uses for this chemical. Formaldehyde is used primarily

as a fumigant in agricultural premises such as poultry and swine farms and processing plants 

as well as in citrus packing and mushroom houses. It is used as a hard surface disinfectant in 

commercial premises, industrial premises and veterinary clinics. Formaldehyde is also 

registered as a materials preservative for consumer products such as laundry detergents, 

general purpose cleaners and wall paper adhesives. 

Paraformaldehyde

Paraformaldehyde is a white crystalline solid formed by polymerization of 

formaldehyde. In 1964, paraformaldehyde was registered as a sanitizer and fungicide for use 

on barber and beauty shop equipment. Currently there are 2 active products under PC Code 

043002. Steri-DriTMFumigant (Registration #397-6) is used as bacteriostat, fungicide, and 

sanitizer in hair/beauty salons and barber shops, and Sun Pac(Registration #4972-43) is used 

primarily as mildewcide in closets and unoccupied vacation homes. There are no inert 

ingredient uses for this chemical. EPA issued a Registration Standard for paraformaldehyde

in May 31, 1988. 

B. Chemical Identification 

Formaldehyde Molecular Structures: 

Figure 1. Formaldehyde (Gas) 

Figure 2. Formaldehyde (In Water) 

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Common Name: Formaldehyde (Gas) 

 Aqueous Formaldehyde solution (in water) 

Chemical Name: Formaldehyde (Gas) 

 Formaldehyde monohydrate (Aqueous solution) 

Other Names: Formaldehyde 

 Formalin

OPP Chemical Codes: 043001

CAS Registry No.: 50-00-0

Case Number: 0556

Empirical Formula: CH

2

O (Gas or anhydrous form) 

 H

2

C(OH)2 or C

1

H

4

O

2 

(Formaldehyde 

 monohydrate) 

Molecular Weight: 30.03 (Gas) 

48.03 (Aqueous solution) 

Manufacturers: Champion Technologies, 

 Hess & Clark, Inc., 

 Baker Petrolite Corporation, 

Highest Percent of 

Active Ingredient: 54% 

Formulation Types Registered: 

 Technical Grade (TGAI): None. 

Manufacturing Use Products (MP): Soluble Concentrate 

End Use Products (EP): Soluble Concentrate, ready to use solution 

Chemical Properties: Formaldehyde gas is colorless with a pungent, suffocating 

 odor; it is readily soluble in water. It has a boiling point 

 of -19.5oC, melting point of -92oC, a density of 0.815 g/mL

at 20oC with a vapor pressure of 3,890 mm Hg @ 25oC. 

Formaldehyde is gas at room temperature and, therefore, 

has no pH. Formaldehyde gas is unstable and can 

 polymerize quite easily. It is corrosive to metals and has a 

 flashpoint of 60oC. 

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Commercially formaldehyde is sold as formalin, a 37% to 

55% by weight aqueous solution in water, usually with 

0.5% to 15% methyl alcohol added to prevent 

polymerization to a solid crystalline form. In water, it 

exists as formaldehyde monohydrate and its chemical 

formula is H

2

C(OH)2.

A 37% Formaldehyde solution is a colorless liquid with a 

pungent odor. It is 100% miscible in water and has a 

boiling point of 101oC. It has a density of 8.75 lbs/gal and 

sp gr. of 1.08 at 20oC. It is soluble in organic solvents such 

as ether, alcohol, acetone and benzene. It has a vapor 

pressure of 1.3 mm Hg at 68oF, and 67- 88 mm Hg at 98oF. 

Paraformaldehyde Molecular Structures: 

Figure 1. Paraformaldehyde 

Figure 2. Paraformaldehyde 

Common Name: Paraformaldehyde 

Chemical Name: Paraformaldehyde 

OPP Chemical Codes: 043002

CAS Registry No.: 30525-89-4

Case Number: 0556

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Empirical Formula: HO(CH

2

O)nH (n = 6 - 100 ) 

Molecular Weight: (30.03)n g/mole 

Manufacturers: Protexall Products Inc 

 Noble Pine Products Co., 

Highest Percent of 

Active Ingredient: 95% 

Formulation Types Registered: 

 Technical Grade (TGAI): None 

Manufacturing Use Products (MP): None 

End Use Products (EP): Crystalline 

Chemical Properties: Paraformaldehyde is a white crystalline solid with an irritating 

odor. It is the polymerized form of formaldehyde. It has a 

melting point of 120 to 170oC, density of 1.46 g/ml at 15oC, 

bulk density of 750 to 850 kg/m3, and sp gr. of 1.4. Solubility

in water is partial and is dependent on pH, temperature and 

molecular weight. It is insoluble in most organic solvents and 

very soluble in dilute alkali and acids. It has a vapor pressure 

of 1.45 mm Hg at 25oC and 1 mm Hg at 30oC. It has a pH of 

3.5- 4.5 and is moderately corrosive 

C. Use Profile 

The following information is a description of the currently registered uses of 

formaldehyde and paraformaldehyde products, and an overview of use sites and 

application methods. A detailed table of the uses for formaldehyde and paraformaldehyde 

that are eligible for reregistration can be found in Appendix A. 

Formaldehyde

Type of Pesticide: Disinfectant (Bacteriocide/ Germicide), Sanitizer, Microbicide/ 

Microbistat, Fungicide 

Use Sites: 

Agricultural premises and equipment

Chicken and Turkey farms 

Swine operations 

Dairy farms

Cattle farms 

Veal farms 

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Emu and ostrich farms 

Federally inspected meat and poultry establishments except where meat and food 

products are handled. 

Poultry and swine premises and confinement areas 

Hatching egg washing/fumigating treatment 

Citrus packing houses 

Iris and daffodil bulbs in bulb farms 

Mushroom houses, equipment and premises 

Commercial, institutional and industrial premises and equipment

Hard non-porous surfaces 

Rooms and Railway cars 

Residential and public access premises

Zoos 

Veterinary clinics, kennels 

Pet shops 

Industrial processes and water systems

Oil recovery injection water systems 

Drilling muds, work over fluids and water based packer fluids 

Formulation Types: soluble concentrate and ready to use 

Methods and Rates of Application: 

A summary of the formaldehyde registered uses is given in Table 1 and a more 

detailed listing is included in Appendix A. Formaldehyde application sites include 

agricultural premises and equipment, railroad car fumigation and oil production. 

Formaldehyde is also registered as an in can preservative for use in consumer products. 

Formaldehyde is not registered for use in paints. 

Table 1: Formaldehyde Use Site and Application Rates 

Use Site Label # Application Rates and Instructions 

In Container Preservative 8133-32 Use range = 0.1 to 1000 ppm in final 

product. 

Poultry and Livestock Bldgs 

and Equipment. Vet Clinics 

and Kennels 

134-65 Spray all surfaces to saturation using 1-3 oz 

product/gallon. 

Wet mist using an automatic wet fogger and 

1 1⁄4 - 2 1⁄2 oz product/gallon. 

Poultry and swine premises 

and confinement areas 

8133-32 Use 20-60 oz. product/1000 ft3. 

Sprinkler application: Use a 1:11 dilution 

Spray Sled: Use a 1:4 dilution 

Egg Hatcher/Incubator 8133-32 Use a maximum of 1 fl. oz./30 ft3. Place in 

an open container and allow to evaporate. 

After the 19th day of incubation, use 1⁄2 fl. 

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Use Site Label # Application Rates and Instructions 

oz/30ft3. 

Citrus packing houses 8133-32 Use 16 fl. oz product/1000 ft3. Apply using a 

stationary mounted spray manifold and 

suitable air operated foggers. Premises may 

be treated up to twice a year. 

Mushroom houses, equipment 

and premises 

8133-32 Non Producing areas: Inject solution into 

steam (1 gallon per 5,500 - 6650 ft3

) 

Rooms and Railway cars 8133-32 For each 1000 ft3, use 16 2/3 oz potassium

permanganate and 20 oz of product. 

Oil recovery injection water 

systems 

8133-28 

10707-43 

Inject 25-5000 ppm active ingredient for 

continuous treatment or slug application. 

Drilling muds, work over 

fluids and water based packer 

fluids 

Inject 100-500 ppm active ingredient for 

continuous treatment or slug application 

Paraformaldehyde

Type of Pesticide: Disinfectant, bacteriocide, algaecide, fungicide 

Use Sites: 

Residential and Public Access Premises

Bathroom premises (cabinets, drawers and closets) 

Kitchen premises (cabinets, drawers and closets) 

Human bedding 

Barber shops and beauty salons (cabinets and drawers) 

Formulation Types: crystalline 

Methods and Rates of Application: 

A summary of the paraformaldehyde registered uses is given in Table 2 and a more

detailed listing is included in Appendix A. 

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Table 2: Paraformaldehyde Use Site and Application Rates 

Use Site Label # Use Instructions 

Closets 

(Clothing and 

Linen) 

4972-43 Hang cloth bag in closet or lay on shelf or in drawer. 

Contents of this bag will treat up to 700 cubic feet. 

For musty odor in bedding, place one bag Sun Pac along 

with mattress, quilts, blankets, sheets in sealed closet space 

no greater than 100 cubic feet. Leave articles 24 hours. 

Vacation Homes 4972-43 When closing home for vacation or season, place one bag 

Sun Pac for each 700 cubic feet of space. Use only in 

unoccupied rooms. Rooms must be ventilated thoroughly 

before reentry. 

Hair/Beauty

Salons and Barber 

Shops 

397-6 Remove cap, place Steri-dri in sanitizer cabinets, implement 

drawers, roller trays, student implement kits, covers or doors 

which are to be kept tightly closed. 

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III. Summary of Formaldehyde and Paraformaldehyde Risk Assessments

The purpose of this summary is to assist the reader by identifying the key features 

and findings of these risk assessments and to help the reader better understand the 

conclusions reached in the assessments. The human health and ecological risk 

assessment documents and supporting information listed in Appendix C were used to 

formulate the safety finding and regulatory decision for formaldehyde and 

paraformaldehyde. While the risk assessments and related addenda are not included in 

this document, they are available from the Federal Government Public Docket at 

www.regulations.gov. The docket identification number is EPA-HQ-OPP-2008-0121.

Hard copies of these documents may be found in the OPP public docket which is located 

in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is 

open Monday through Friday, excluding Federal holidays, from 8:30 a.m.to 4:00 p.m. 

The Agency’s use of human studies in the formaldehyde and paraformaldehyde 

risk assessment is in accordance with the Agency's Final Rule promulgated on January 

26, 2006, related to Protections for Subjects in Human Research, which is codified in 40 

CFR Part 26. 

A. Human Health Risk Assessment 

1. Toxicity of Formaldehyde and Paraformaldehyde 

A brief overview of the toxicity studies used for determining endpoints in the risk 

assessments are outlined below in Table 3. Further details on the toxicity of 

formaldehyde and paraformaldehyde can be found in the Formaldehyde: Toxicology 

Disciplinary Chapter for the Reregistration Eligibility Decision (RED) Document, dated 

3/31/2008; and Formaldehyde: Risk Assessments for the Reregistration Eligibility 

Decision (RED) Document, dated 4/7/2008. These documents are available on the U.S. 

Federal Government Public Docket website at www.regulations.gov (Docket ID #EPAHQ-OPP-2008-0121). 

The Agency has reviewed all toxicity studies submitted to support guideline 

requirements for formaldehyde and paraformaldehyde and determined that the 

toxicological database is sufficient for reregistration. Major features of the toxicology 

profile are presented below. 

a. Acute Toxicity 

The acute toxicity database for formaldehyde is considered complete. Technical 

grade formaldehyde (37% a.i.) has a moderate order of acute toxicity in experimental 

animals via the oral and dermal routes (Toxicity Categories II and III). Inhalation toxicity 

studies on formaldehyde are extensive and include both acute exposures and longer term 

exposures. Toxicity from acute exposures is characterized by pathology of the respiratory 

epithelium and has been observed in rats exposed for 4 hours to a concentration of 10 

10 of 87 
ppm (Bhalla, 1991), while longer term exposures of rats (3 ppm for 6 hours/day for 5 

days) also results in respiratory tract lesions (Buckley et al., 1984). Table 3 gives a 

summary of the acute toxicity data. 

 Table 3. Acute Toxicity data for Formaldehyde technical a.i. 

Guideline 

Number 

Study Type/ Test substance 

(% a.i.) 

MRID 

Number/ 

Citation 

Results Toxicity 

Category

870.1100 

(§81-1)

Acute Oral – Guinea Pig 

Purity 37.3% - Formaldehyde

00058054 LD50 = 260 mg/kg II 

870.1200 

(§81-2)

Acute Dermal – Rat 

Purity 37.3% - Formaldehyde

00058054 LD50 = 300 mg/kg II 

870.1200 

(§81-2)

Acute Dermal – Rabbit

Purity 37.3% - Formaldehyde

00058054 LD50 = 240 mg/kg II 

870.1200 

(§81-2)

Acute Dermal – Dog 

Purity 37.3% - Formaldehyde

00058054 LD50 = 550 mg/kg II 

870.1300 

(§81-3)

Acute Inhalation – Mouse and Rat See Open Literature studies in Toxicity Profile for 

Formaldehyde

870.2400 

(§81-4)

Primary Eye Irritation -

Purity 37.3% - Formaldehyde

00058054 Severe eye irritant I 

870.2500 

(§81-5)

Primary Dermal Irritation

Purity 37.3% - Formaldehyde

00058054 Formation of vesicles 

with superficial necrosis 

or nodules. 

I 

870.2600 

(§81-6)

Dermal Sensitization – Guinea pigs

Purity 40.0% - Formaldehyde

40161103 Extreme Sensitizer NA 

b. Toxicological Endpoints 

On June 12, 2008, members of the Antimicrobials Division's Toxicity 

endpoint Selection Committee (ADTC) met to discuss the non-cancer inhalation toxicity 

endpoint for formaldehyde that had been previously selected by the committee for use in 

conducting inhalation toxicity risk assessments for the formaldehyde reregistration 

eligibility decision (RED) document. 

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The original endpoint of 100 ppb was selected from the published report of 

Horvath et. al., [JAMA 259, no. 5: 701-707, 1988], who reported nasal and respiratory 

effects in 109 workers occupationally exposed to formaldehyde. The value of 100 ppb 

was selected as a NOAEL for use in occupational risk assessments, while for the general 

population; a value of 10 ppb was selected. This value was derived by application of a 

10-fold uncertainty factor to the NOAEL value of 100 ppb to account for intraspecies 

variation in response in accordance with Agency policy. 

During the public comment phase of the formaldehyde risk assessment, the 

Formaldehyde Council responded to the selection of the 100 ppb endpoint. They stated 

that the Agency should consider the results of a 2007 publication by Noisel et al. 

(Regulatory Toxicology and Pharmacology 48: 118-127), which reviewed some of the 

available scientific literature. This study, in the Council's opinion, "is based on human 

exposure rather than controlled human chamber studies and can be used for deriving a 

No-Observed-Adverse-Effect-Level (NOAEL) for the non-cancer endpoint for 

formaldehyde." 

The ADTC noted both observational human exposure data as well as data 

compiled from exposure of human subjects under controlled conditions in the Noisel et. 

al., publication. Notwithstanding the need for intentional exposure data to be presented 

to the Agency's Human Studies Review Board, the ADTC noted that irritant effects of 

formaldehyde have been reported in other studies below the 0.75 ppm concentration 

recommended by Noisel et. al., as a safe level. Further, this recommendation is for 

worker populations only. 

The irritant effects of formaldehyde, including both eye and nasal irritation as 

well as respiratory symptoms (irritation, changes in pulmonary function), can be 

considered from a toxicological perspective to be composed of both physiological and 

adverse responses. Based on the available data, the ADTC was not compelled to select a 

value higher than that already proposed. With respect to the 10-fold uncertainty factor 

used for risk assessment to the general population, the ADTC concluded that a reduction 

in this factor is not warranted at this time. Contrary to the Formaldehyde Council's 

statement that "the nature of the health effect does not suggest that there are particularly 

susceptible subpopulations which would warrant application of the 10x intraspecies UF," 

the 1999 ATSDR Toxicological Review of formaldehyde (ATSDR, 1999) noted two 

studies "...providing suggestive evidence that children may be more sensitive to the 

irritant effects of formaldehyde." These studies were not intentional exposure studies. It 

is also noted in the ATSDR review that "additional research is necessary to confirm or 

discard the hypothesis that children may be more susceptible than adults to the irritant 

effects of formaldehyde..." 

The ADTC concluded that, based on the available data, it is appropriate to remain 

with the NOAEL value selected from the 1988 Horvath et. al., publication and with the 

10-fold uncertainty factor for risk assessments to the general population. The ADTC is 

also aware, however, of ongoing efforts by ORD/NCEA to develop an inhalation 

reference concentration, or RfC for formaldehyde. OPP will continue to coordinate its 

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efforts with ORD and other program offices to refine the non-cancer inhalation 

assessment as necessary. The toxicological endpoints selected for various exposure 

scenarios are summarized below in Table 4.

Table 4. Toxicology Endpoint Selection for Formaldehyde 

Exposure 

Scenario

Dose Used in Risk

Assessment 

(mg/kg/day)

Target MOE, UF, 

Special FQPA SF* 

for Risk Assessment

Study and Toxicological 

Effects

Dietary Risk Assessments

Acute Dietary

(general 

population 

including infants 

and children) 

An acute dietary assessment is not needed for the registered antimicrobial uses of 

formaldehyde. 

Chronic Dietary

(all populations) 

A chronic dietary assessment is not needed for the registered antimicrobial uses of 

formaldehyde. 

Non-Dietary Risk Assessments

Incidental Oral An incidental oral risk assessment is not required for the registered antimicrobial uses of 

formaldehyde. 

Dermal (all 

durations) 

A dermal risk assessment is not required for the registered antimicrobial uses of 

formaldehyde. 

Inhalation

(all durations) 

NOAEL (human) = 

0.1 ppm

Occupational UF = 1 

Residential UF = 10 (10x

intraspecies)

 ACGIH 2001 publication on 

formaldehyde

Horvath, E.P. et. al., (1986): 

JAMA 259(5): 701-707. Based on 

complaints of eye, nose, and throat 

irritation in particle board workers 

at concentrations of formaldehyde 

from 0.4 – 1.0 ppm. 

Redden, J. (2005): Section 18 

Emergency Exemption for the use 

of Paraformaldehyde: U.S. Army

Medical Research Institute of 

Infectious Diseases.

Cancer Formaldehyde is currently classified as a B1 (probable human carcinogen) in EPA’s IRIS 

assessment. IARC has classified formaldehyde as “carcinogenic to humans.” The Agency

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/m3

) and the CIIT BBDR model until 

any new cancer estimates are fully peer reviewed. 

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c. Carcinogenicity 

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 (Office of Pesticide 

Programs [OPP], Office of Pollution, Prevention, and Toxics [OPPT], Office of Research 

and Development /National Center for Environmental Assessment [ORD/NCEA], Office 

of Research and Development/National Health Effects Exposure Research Laboratory 

[ORD/NHEERL], and Office of Air and Radiation [OAR]). 

• 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/m3) ) 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, 

and 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 peerreviewed journals (2001, 2002, 2003, and 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 Maximale 

Arbeitsplatzkonzentrationen (MAK) Commission have also used the CIIT model. 

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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. 

• 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. 

• 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 California’s Office of Environmental Health 

(OEHHA)’s November 2002 evaluation of a petition had included the 1999 report 

on the CIIT model and other information, and that 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 nonlinear 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). 

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• 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.showChe

mical&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 on 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/m3) 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. 

2. FQPA Safety Factor 

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, an FQPA safety finding is not applicable. 

3. Dietary and Drinking Water Risk 

Formaldehyde is used to treat mushroom houses, equipment and premises and 

citrus facilities as a disinfectant treatment when food is not present. The Agency believes 

that the dietary exposure from citrus packing and mushroom houses will be negligible. In 

addition, formaldehyde is used as a materials preservative in dishwashing detergent. 

Formaldehyde is a gas at room temperature and it is dissolved in water. However, 

formaldehyde is not stable in water and has a tendency to escape from solution. Half 

lives in air and water are short, so it is unlikely formaldehyde persists on pots, pans, and 

dishes. In addition, it is not expected to contaminate ground water. Therefore, there are 

no dietary or drinking water concerns from the antimicrobial uses of formaldehyde. 

4. Residential Exposure and Risk 

The residential exposure assessment considers all potential pesticide exposure, 

other than exposure due to residues in food or in drinking water. Each route of exposure 

(oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as an MOE 

(Margin of Exposure) which is the ratio of estimated exposure to an appropriate NOAEL 

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(No Observed Adverse Effect Level). Estimated MOEs are then compared to the Target 

MOE, which represents the dose selected for risk assessment and uncertainty factors (UF) 

applied to that dose. The standard UF is 100x, which includes 10x for interspecies 

extrapolation (to account for differences between laboratory animals and humans) and 

10x for intraspecies variation (to account for differences within the same species). 

There is one product containing formaldehyde that is labeled for use as in can 

preservative of consumer products such as laundry detergents, general purpose cleaners 

and wall paper adhesives. Use of these products can result in residential handler 

exposure. In addition, there is one paraformaldehyde mildewcide product that is labeled 

for treatment of closets and vacation homes. Use of this product could result in 

residential postapplication exposure to paraformaldehyde. The exposure scenarios for 

residential exposure are provided in Table 5. Additional information on the residential 

exposures to formaldehyde and paraformaldehyde can be found in the Formaldehyde: 

Revised Occupational and Residential Exposure Assessment for the Reregistration 

Eligibility Decision (RED) Document, dated 4/15/2008; and Formaldehyde: Risk 

Assessments for the Reregistration Eligibility Decision (RED) Document, dated 4/7/2008. 

These documents are available on the Federal Government Public Docket website at 

www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121). No updated risk 

assessments to reference?

Table 5. Exposure Scenarios for Formaldehyde and Paraformaldehyde 

Use Exposure Scenario Application Rate (ppm)

Residential Handler Inhalation Exposures from Formaldehyde Uses 

Material Preservation of 

Laundry Detergent 

Handler Exposure While Using Treated

Laundry Detergent 1000 ppm product

Material Preservation of 

Floor and Furniture Polish

and Detergent Products 

Handler Exposure While Using Treated

General Purpose Cleaners 

150 ppm product 

Material Preservation of Wall 

Paper Adhesive

Handler Exposure While Using Treated

Wallpaper Adhesive 100 ppm product 

Residential Postapplication Inhalation Exposures from Paraformaldehyde Uses 

Mildewcide for clothing and 

linen in closets

Post Application Exposure 4 ounce of product per 750 ft3

Mildewcide for Vacation 

Homes 

Post Application Exposure 4 ounce of product per 750 ft3

Material Preservation of Wall 

Paper Adhesive

Post Application Exposure from Wallpaper 

Adhesive 

100 ppm product 

a. Formaldehyde Residential Handler Risk 

Residential handler inhalation exposures were assessed for handlers of 

formaldehyde treated laundry detergent, general purpose cleaners and wall paper 

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adhesives. The EPA’s Consumer Exposure Module (CEM) was used to estimate air 

concentrations resulting from the use of laundry detergent and general purpose cleaner 

preserved with formaldehyde. The EPA’s Wall Paint Exposure Model (WPEM) was 

used to estimate handler inhalation as well as post application exposures resulting from

the use of wall paper adhesive preserved with formaldehyde. 

A summary of the residential risks for formaldehyde is included in Table 6. The 

non-cancer risks are of concern for three of the scenarios because the MOEs are less than 

the target MOE of 10. The non-cancer risk estimates are based upon EPA exposure 

models which are generally believed to be conservative. The fact that the vapor pressure 

of 1.0 mm Hg, which is based on formaldehyde as formalin, was used in these models 

rather than the vapor pressure of pure formaldehyde, which exists only as gas, is a source 

of uncertainty. There are also uncertainties regarding the use of the WPEM model 

because it is based on test data for paint solvents that have different physical/chemical 

properties than formaldehyde. 

The estimated cancer risks range from <3 x 10-9 when using the CIIT model to 8 x 

10-6 when using the IRIS unit risk. The IRIS cancer risk estimates provide an upperbound on risk. Based on the on going reevaluationf the potential cancer and non-cancer 

risks of formaldehyde through the ORD Integrated Risk Information System (IRIS) 

program, a reevaluation may need to be done at a later date. 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. 

Table 6 – Residential Risk Summary for Biocidal Uses of Formaldehyde 

Scenario Peak Air 

Concentration

MOE 

(Target 

MOE =10) 

LADC Cancer Risk 

IRIS CIIT 

Laundry Detergent 

Handler 240 ppb 0.4 0.5 ppb 8 x 10-6 <3 x 10-9

General Purpose 

Cleaner Handler 21 ppb 4.8 0.12 ppb 2 x 10-6 <3 x 10-9

Wall Paper Adhesive 

Handler 15 ppb 6.7 0.044 ppb 7 x 10-7 <3 x 10-9

Wall Paper Adhesive 

Post Application 4.9 ppb 20 0.038 ppb 6 x 10-7 <3 x 10-9

b. Formaldehyde Residential Post Application Risk 

The EPA’s Wall Paint Exposure Model (WPEM) was used to estimate post 

application exposures resulting from the use of wall paper adhesive preserved with 

formaldehyde. The MOE for peak exposure is 20 and is not of concern. The estimated 

cancer risk ranges from <3 x 10-9 when using the CIIT model to 6 x 10-7 when using the 

IRIS unit risk. 

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c. Paraformaldehyde Handler Residential Risk 

Based on current use patterns, there are no residential handler exposures 

anticipated from the use of paraformaldehyde. 

d. Paraformaldehyde Post Application Residential Risk 

The EPA’s Consumer Exposure Module (CEM) was used to estimate post 

application inhalation exposures resulting from the use of paraformaldehyde mildewcide 

in closets of occupied homes. The MOE for the mildewcide use is less than 0.1, which is 

below the target MOE of a10 and is of concern. The estimated cancer risk ranges from

<8 x 10-7 when using the CIIT model to 3 x 10-3 when using the IRIS unit risk.

Conversations with the registrant of this product have indicated that it is primarily 

intended to be used in unoccupied homes. Although these products are used in 

unoccupied homes, the risks for the closet scenario are of concern because of potential 

difficulty providing thourough ventilation before reentry. For this reason, use in closets 

and other confined spaces present risk concerns.

5. Aggregate Risk 

The Food Quality Protection Act amendments to the Federal Food, Drug, and 

Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require “that there is reasonable 

certainty that no harm will result from aggregate exposure to pesticide chemical residue, 

including all anticipated dietary exposures and other exposures for which there are 

reliable information.” Aggregate exposure is the total exposure to a single chemical (or 

its residues) that may occur from dietary (i.e., food and drinking water), residential, and 

other non-occupational sources, and from all known or plausible exposure routes (oral, 

dermal, and inhalation). Acute and chronic dietary aggregate assessments were not 

conducted for formaldehyde because there are no uses for formaldehyde attributable to 

the dietary route of exposure. 

6. Occupational Exposure and Risk 

a. Occupational Handler Exposure and Risk 

Workers can be exposed to formaldehyde through mixing, loading, applying a 

pesticide or re-entering treated sites. Formaldehyde is used as a fumigant for agricultural 

premises, in preservation, in production, and in wall paper adhesive. The Agency has 

very little information concerning exposure from biocidal uses for formaldehyde. 

Because formaldehyde has a high vapor pressure (1.0 mm Hg in formalin), the inhalation 

unit surrogate exposure data that are often used to estimate risks associated with pesticide 

use are generally not applicable. Although there are many studies of formaldehyde 

occupational exposures reported in the literature, these studies involved the non-biocidal 

uses. Therefore, it was not possible to quantitatively assess the formaldehyde exposures 

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that result from biocide uses; a qualitative assessment was completed based upon work 

practices listed on the labels. 

In general, it was determined for the biocide application scenarios that if the label 

requirements such as closed system loading, remote application and adequate ventilation 

are followed, exposures would be reduced to levels that are not of concern. There are 

several occupational handler exposure scenarios that involve formaldehyde products. 

These scenarios are listed below: 

• Mechanical Fumigation 

• Evaporative Fumigation 

• Catalyzed Evaporative Fumigation 

• Hard Surface Disinfection of Animal Housing Areas and Equipment 

• Material Preservation 

• Oil Production 

• Wall Paper Adhesive Application 

The wall paper adhesive application was assessed using the WPEM model. The 

MOE for non-cancer risk is 1.6 which is above the target MOE of 1 and is thus not of 

concern. The estimated cancer risk ranges from <1 x 10-8 when using the CIIT model to 

6 x 10-5 when using the IRIS unit risk. For additional information, please see the 

Formaldehyde: Revised Occupational and Residential Exposure Assessment for the 

Reregistration Eligibility Decision (RED) Document, dated 4/15/2008; located on the 

Federal Government Public Docket website at www.regulations.gov (Docket ID #EPAHQ-OPP-2008-0121). 

b. Occupational Post Application Exposure and Risk 

Formaldehyde is used for fumigating poultry and swine containment buildings 

and post application exposure can occur when the workers re-enter the fumigated areas. 

These exposures were assessed using the single chamber decay formula from the MultiChamber Concentration and Exposure Model (MCCEM) and a ventilation rate of 4 air 

changes per hour. This assessment was based upon the application parameters listed in 

the Champion Technologies Formaldehyde Solution 37 Label (EPA Reg #8133-32). The 

ventilation rate is based upon poultry and animal housing design criteria; given these 

conditions, the formaldehyde air concentration declines to a level that is not of concern 

after 3 hours. For additional information, please see the Formaldehyde: Revised 

Occupational and Residential Exposure Assessment for the Reregistration Eligibility 

Decision (RED) Document, dated 4/15/2008; located on the Federal Government Public 

Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121). 

7. Human Incident Data 

There are many reported incidents associated with formaldehyde exposure, but 

only a limited few are associated with its use as an antimicrobial agent (biocide). 

Formaldehyde is a dermal irritant and a dermal sensitizer. The primary dermal effects 

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that have been reported are rash, burning sensation, itching, dry scaling irritation, 

cracking and thickened skin, itching, and blisters and rash on hands. Symptoms

associated with eyes are the primary reported illness in all associated incidents. Nausea,

dizziness, headache, and sore throat are the primary systemic effects that have been 

reported. Allergic reactions and asthma-like symptoms also have been reported 

following occupational exposures. Only limited acute cases with oral exposure to 

formaldehyde have been published in scientific literature. For additional information on 

the reported incidents, refer to the Incidents Report Associated with Formaldehyde, dated 

1/30/2008; located on the Federal Government Public Docket website at 

www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121). 

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B. Environmental Risk Assessment 

A summary of the Agency’s environmental risk assessment is presented below. 

The following risk characterization is intended to describe the magnitude of the estimated 

ecological hazards and environmental risks for formaldehyde and paraformaldehyde. 

Based on the registered antimicrobial use patterns, formaldehyde and paraformaldehyde 

have low potential for terrestrial or aquatic environmental exposure. Therefore, a 

quanitatiave risk assessment was not conducted. 

For detailed discussions of all aspects of the environmental risk assessment, see 

the Environmental Fate Assessment of Formaldehyde for the Issuance of the 

Reregistration Eligibility Decision Document, dated January 23, 2008, and the Ecological 

Hazard and Environmental Risk Assessment of Formaldehyde and Paraformaldehyde for 

the Reregistration Eligibility Decision (RED) Document, dated January 29, 2008. 

1. Environmental Fate and Transport 

The Agency has no environmental fate and transport data for formaldehyde or 

paraformaldehyde and relied on open literature for fate and transport studies. Available 

literature indicates that there are multiple degradation pathways for formaldehyde. 

Paraformaldehyde off-gasses as formaldehyde from a formaldehyde/paraformaldehyde 

solution; therefore, the Agency has assumed that paraformaldehyde will have fate and 

transport behavior similar to formaldehyde. 

a. Water 

The half-life of formaldehyde has been reported between 24-168 hours (1-7 days) 

in surface water and 48-336 hours (2- 14 days) in groundwater, based on estimated 

aqueous aerobic biodegradation half lives. Formaldehyde, therefore, is not likely to 

persist in natural waters. The Agency for Toxic Substances and Disease Registry 

(ATSDR) notes that when formaldehyde is released into water it biodegrades to low 

levels in a few days. 

b. Soil 

A Koc value of 1.567 was estimated for formaldehyde based on open literature 

(ATDSR, 19991

) therefore, it is not expected to adsorb to soils and is likely to be mobile 

in soils. Compounds with a Koc value of less than <100 are considered to be moderately 

mobile in soils and may contaminate groundwater. Octanol/Water partition is low (log 

Kow = 0.65). Therefore formaldehyde is not likely bioaccumulate in aquatic organisms. 

1

 ATSDR (Agency for Toxic Substances and Disease Registry). Toxicological Profile for Formaldehyde. 

U.S. Department of Health and Human Services. 1999. 

22 of 87 
c. Air 

The half life of formaldehyde in air has been found to depend on intensity of 

natural light, temperature, and location. Based on its reaction with hydroxy radical using 

hydroxyl radical rate constant, the half life of formaldehyde in air varies between 7 to 70 

hours. One study even estimated the air half life to vary between 0.3 to 250 hours. This 

study, however, assumed there was hydroxyl or hydroperoxyl radicals present. It is not 

likely to persistent in air. Degradation products from this interaction likely are: water, 

formic acid, carbon monoxide and an intermediate adduct likely 

hydroperoxyl/formaldehyde. Air photolytic half life of formaldehyde has been estimated 

between 1.6 to 6 hours. 

2. Ecological Hazard 

Formaldehyde and paraformaldehyde labeled uses including oil field uses such as 

treatments of drilling muds and waterfloods are considered by the Agency to pose little 

adverse risk to non-target organisms or listed species. Antimicrobial pesticides used in oil 

fields are typically minor use chemicals, diluted and greatly reduced before discharge 

into water, and are often regulated by other Federal or EPA offices (OW, Office of Solid 

Waste, OPPTS, state NPDES permits). In the case of oil fields, the US Department of the 

Interior, Minerals Management Service (MMS) had jurisdiction over the environmental 

impacts of synthetic drilling fluids in terrestrial and aquatic areas. 

Terrestrial oil fields typically use berms and catch basins to prevent surface runoff 

of oil drilling muds and wastes from oil drilling areas. Estuarine and marine aquatic 

organisms may be temporarily exposed during marine drilling; however, impacts are 

limited to a defined area around the oil well (Neff, 2000). If the pesticide is to be used in 

estuarine or marine environments, three additional acute estuarine/marine toxicity studies 

are required. The ecological hazard assessment has determined that formaldehyde 

product labels must state: “This product is toxic to oysters.” 

3. Risk to Listed Species

Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2), 

requires that federal agencies consult with the National Marine Fisheries Service (NMFS) 

for marine and andronomus listed species, or with the United States Fish and Wildlife 

Services (FWS) for listed wildlife and freshwater organisms, if proposing an "action" that 

may affect listed species or their designated habitat. Each federal agency is required 

under the Act to insure that any action they authorize, fund, or carry out is not likely to 

jeopardize the continued existence of a listed species or result in the destruction or 

adverse modification of designated critical habitat. To jeopardize the continued existence 

of a listed species is to "to engage in an action that reasonably would be expected, 

directly or indirectly, to reduce appreciably the likelihood of both the survival and 

recovery of a listed species in the wild by reducing the reproduction, numbers, or 

distribution of the species." 50 C.F.R. §402.02. 

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To comply with subsection (a)(2) of the ESA, EPA’s Office of Pesticide 

Programs has established procedures to evaluate whether a proposed registration action 

may directly or indirectly appreciably reduce the likelihood of both the survival and 

recovery of a listed species in the wild by reducing the reproduction, numbers, or 

distribution of any listed species (U.S. EPA 2004). If any of the Listed Species LOC 

Criteria are exceeded for either direct or indirect effects in the Agency’s screening-level 

risk assessment, the Agency identifies any listed or candidate species that may occur 

spatially and temporally in the footprint of the proposed use. Further biological 

assessment is undertaken to refine the risk. The extent to which any species may be at 

risk determines the need to develop a more comprehensive consultation package as 

required by the ESA. 

For certain use categories, including all current formaldehyde and 

paraformaldehyde uses, the Agency assumes there will be minimal environmental 

exposure, and only a minimal toxicity data set is required (Overview of the Ecological 

Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental 

Protection Agency - Endangered and Threatened Species Effects Determinations, 

1/23/04, Appendix A, Section IIB, p 81). Uses in these categories do not undergo a full 

screening-level risk assessment and are considered to generally fall under a “no effect” 

determination, however, an endangered species effect determination will not be made at 

this time. 

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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision

A. Determination of Reregistration Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission 

of relevant data concerning an active ingredient, whether or not products containing the 

active ingredient are eligible for reregistration. The Agency has previously identified and 

required the submission of the generic (i.e., active ingredient-specific) data required to 

support reregistration of products containing formaldehyde and paraformaldehyde as an 

active ingredient. The Agency has completed its review of these generic data and has 

determined that the data are sufficient to support reregistration of virtually all supported 

products containing formaldehyde and paraformaldehyde. 

The Agency has completed its assessment of the residential, occupational and 

ecological risks associated with the use of pesticide products containing the active 

ingredient formaldehyde and paraformaldehyde. The Agency has determined that 

virtually all formaldehyde and paraformaldehyde containing products are eligible for 

reregistration provided that: 1) all risk mitigation measures are implemented; 2) current

data gaps and confirmatory data needs are addressed; and 3) label amendments are made 

as described in Section V. Use in confined spaces such as closets is not eligible for 

registration because of the difficulty associated with ventilation of these spaces. 

Appendix A summarizes the uses of formaldehyde and paraformaldehyde that are eligible 

for reregistration. Appendix B identifies the generic data requirements that the Agency 

reviewed as part of its determination of reregistration eligibility of formaldehyde and 

paraformaldehyde and lists the submitted studies that the Agency found acceptable. Data 

gaps are identified as generic data requirements that have not been satisfied with 

acceptable data. 

Based on its evaluation of formaldehyde and paraformaldehyde, the Agency has 

determined that formaldehyde and paraformaldehyde products, unless labeled and used as 

specified in this document, would present risks inconsistent with FIFRA. Accordingly, 

should a registrant fail to implement the risk mitigation measures, submit confirmatory 

data as well as make the label changes identified in this document, the Agency may take 

regulatory action to address the risk concerns from the use of formaldehyde and 

paraformaldehyde. If all changes outlined in this document are fully complied with, then 

no risks of concern exist for the registered uses of formaldehyde and paraformaldehyde 

and the purposes of this determination. Once an endangered species assessment is 

completed, further changes to these registrations may be necessary as explained in 

Section III of this document. 

B. Public Comments and Responses

Through the Agency’s public participation process, EPA worked with 

stakeholders and the public to reach the regulatory decision for formaldehyde and 

paraformaldehyde. EPA released its preliminary risk assessment for formaldehyde and 

paraformaldehyde for public comment on April 23, 2008. The Agency received a 

comment from the registrant, as well as the Formaldeyde Council, during the 60-day 

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public comment period, which closed on March 23, 2008. The comments included 

suggestions to refine the endpoint selection. 

C. Regulatory Rationale

The Agency has determined that formaldehyde and paraformaldehyde are eligible 

for reregistration provided that risk mitigation measures are implemented as outlined in 

this document, additional required data confirm this decision and label changes are made 

accordingly. Where labeling revisions are warranted, specific language is set forth in the 

summary tables of Section V of this document. 

1. Human Health Risk Management

a. Residential Risk Mitigation for Formaldehyde 

In order to address the risks of concern identified for the laundry detergent, 

general purpose cleaner and wall paper adhesive uses, maximum allowable application 

rates need to be reduced. The non-cancer risks (i.e., MOEs) would require product rate 

reductions to 40 ppm, 72 ppm and 67 ppm for the laundry detergent, general purpose 

cleaner and wall paper adhesive handler scenarios, respectively to achieve the target 

MOE of 10. However, the registrant has requested voluntary cancellation of the laundry 

detergent use. The non-cancer risk for the wall paper post application scenario does not 

require a product rate reduction. In terms of potential cancer risks, the Agency believes 

that the mitigation required for the non-cancer risks will adequately address these risks as 

well regardless of which of the current cancer approaches are used. 

b. Occupational Risk Mitigation for Formaldehyde 

In order to reduce potential occupational handler exposures the following mitigation is 

required: 

• For industrial uses of formaldehyde closed systems with dry couplers (or 

equivilant) are required 

• Structures that may be fumigated are limited to animal premises such as poultry 

houses and swine houses, mushroom houses, citrus packing houses, egg facilities 

and rail cars (not in-transit). 

• All fumugiated uses must be done in such a way that the operator is outside the 

structure undergoing fumigation when applying the fog.

• The labels must be updated to eliminate cloth or mop applications of 

formaldehyde. 

• Manual spray applications of formaldehyde solutions require the use of a full face 

respirator. 

• After fumigating poultry/swine containment buildings, re-entry by unprotected 

persons should be allowed only after a total 12 air changes. (e.g., 3 hours of 

ventilation at a rate of 4 air changes per hour (ACH)) 

26 of 87 
e. Occupational and Residential Risk Mitigation for 

 Paraformaldehyde 

 To mitigate the occupational risks from paraformaldehyde use in beauty salons 

and barber shops, it is necessary that these areas have general ventilation that meets the 

American Society of Heating, Refrigerating and Air-conditioning Engineers (ASHRAE) 

recommendations and/or local exhaust ventilation that meets ACGIH recommendations. 

 To mitigate the residential risks from paraformaldehyde use in vacation homes, 

use must be limited to unoccupied structure that can be thoroughly ventilated six (6) 

hours prior to re-occupancy. 

2. Other Labeling Requirements

In order to be eligible for reregistration, various use and safety information will be 

included in the labeling of all end-use products containing formaldehyde and 

paraformaldehyde. For the specific labeling statements and a list of outstanding data, 

refer to Section V of this RED document. 

27 of 87 
V. What Registrants Need to Do

The Agency has determined that formaldehyde and paraformaldehyde are eligible 

for reregistration provided that: (i) additional data that the Agency intends to require

confirm this decision; (ii) the risk mitigation measures outlined in this document are 

adopted; and (iii) label amendments are made to reflect these measures. To implement 

the risk mitigation measures, the registrants must amend their product labeling to 

incorporate the label statements set forth in the Label Changes Summary Table in Section 

B below (Table 8). The additional data requirements that the Agency intends to obtain 

will include, among other things, submission of the following: 

For formaldehyde and paraformaldehyde technical grade active ingredient 

products, the registrant needs to submit the following items: 

Within 90 days from receipt of the generic data call-in (DCI): 

1. Completed response forms to the generic DCI (i.e., DCI response form and 

requirements status and registrant’s response form); and 

2. Submit any time extension and/or waiver requests with a full written 

justification.

Within the time limit specified in the generic DCI: 

1. Cite any existing generic data which address data requirements or submit new 

generic data responding to the DCI. 

Please contact ShaRon Carlisle at (703) 308-6427 with questions regarding generic 

reregistration. 

By US mail: By express or courier service: 

Document Processing Desk Document Processing Desk 

ShaRon Carlisle ShaRon Carlisle 

Office of Pesticide Programs Office of Pesticide Programs

(7510P) (7510P) 

U.S. Environmental Protection Agency U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900 

Washington, DC 20460-0001 2777 South Crystal Drive 

 Arlington, VA 22202 

28 of 87 
For end-use products containing the active ingredient formaldehyde and 

paraformaldehyde, the registrant needs to submit the following items for each product.

Within 90 days from the receipt of the product-specific data call-in (PDCI): 

1. Completed response forms to the PDCI (i.e., PDCI response form and 

requirements status and registrant’s response form); and 

2. Submit any time extension or waiver requests with a full written justification. 

Within eight months from the receipt of the PDCI: 

1. Two copies of the confidential statement of formula (EPA Form 8570-4); 

2. A completed original application for reregistration (EPA Form 8570-1). 

Indicate on the form that it is an “application for reregistration”; 

3. Five copies of the draft label incorporating all label amendments outlined in 

Table 26 of this document; 

4. A completed form certifying compliance with data compensation requirements 

(EPA Form 8570-34); 

5. If applicable, a completed form certifying compliance with cost share offer 

requirements (EPA Form 8570-32); and 

6. The product-specific data responding to the PDCI. 

Please contact Marshall Swindell at (703) 308-6341 with questions regarding 

product reregistration and/or the PDCI. All materials submitted in response to the PDCI 

should be addressed as follows: 

By US mail: By express or courier service: 

Document Processing Desk Document Processing Desk 

Marshall Swindell Marshall Swindell 

Office of Pesticide Programs (7510P) Office of Pesticide Programs (7510P)

U.S. Environmental Protection Agency U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard 

Washington, DC 20460-0001 2777 South Crystal Drive 

 Arlington, VA 22202 

29 of 87 
A. Manufacturing Use Products

1. Additional Generic Data Requirements

The generic database supporting the reregistration of formaldehyde and 

paraformaldehyde has been reviewed and determined to be substantially complete. 

However, the following additional data requirements have been identified by the Agency 

as confirmatory data requirements and are included in the generic data-call-in (DCI) for 

this RED. Table 8 provides an outline of the requested confirmatory data for 

formaldehyde and paraformaldehyde. 

Table 8. Confirmatory and Conditional Data for Formaldeyde and Paraformaldehyde

Guideline Study Name New OPPTS Guideline Number 

Human Health Confirmatory Data

90-Day Dermal Toxicity 870.3250 

Developmental Toxicity in Non-Rodents 870.3700 

Environmental Fate & Ecological Exposure Confirmatory Data

Acute Daphnia magna using TGAI formaldehyde 850.1010

2. Labeling for Manufacturing Use Products 

To ensure compliance with FIFRA, technical and manufacturing-use product 

(MP) labeling should be revised to comply with all current EPA regulations, PR Notices 

and applicable policies. The Technical and MP labeling should bear the labeling 

contained in Table 9, Label Changes Summary Table. 

B. End-Use Products

1. Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding the pesticide after a determination of eligibility has been made. 

The Registrant must review previous data submissions to ensure that they meet current 

EPA acceptance criteria and if not, commit to conduct new studies. If a registrant 

believes that previously submitted data meet current testing standards, then the study 

MRID numbers should be cited according to the instructions in the Requirement Status 

and Registrants Response Form provided for each product. A product-specific data call-in 

will be issued at a later date. 

2. Labeling for Technical and End-Use Products

Labeling changes are necessary to implement measures outlined in Section IV 

above. Specific language to incorporate these changes is specified in Table 9 Label 

Changes Summary Table. 

Registrants may generally distribute and sell products bearing old labels/labeling 

for 26 months from the date of the issuance of this Reregistration Eligibility Decision 

30 of 87 
31 of 87 

document. Persons other than the registrant may generally distribute or sell such 

products for 52 months from the approval of labels reflecting the mitigation described in 

this RED. However, existing stocks time frames will be established case-by-case, 

depending on the number of products involved, the number of label changes, and other 

factors. Refer to “Existing Stocks of Pesticide Products; Statement of Policy,” Federal 

Register, Volume 56, No. 123, June 26, 1991. 

a. Label Changes Summary Table

In order to be eligible for reregistration, all product labels must be amended to 

incorporate the risk mitigation measure outlined in Section IV of the formaldehyde and 

paraformaldehyde RED. The following table describes how language on the labels 

should be amended. 
Table 9 Labeling Changes Summary Table 

FORMALDEHYDE

Description Amended Labeling Language 

All End Use Products 

Environmental HazardsStatements Required by the RED and Agency Label Policies 

"This pesticide is toxic to oysters. Do not discharge effluent containing this product into lakes,streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination System (NPDES) permit and the permittingauthority has been notified in writing prior to discharge. Do not discharge effluent containingthis product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA." 

Directions For Use 

End Use Products Intended for Poultry/ Swine ContainmentBuildings

“A minimum re-entry time of 3 hours into the fumigated area is required” 

End Use Products Intended for Occupational Disinfectant use 

ALL Labels must be updated to eliminate mop and cloth or sponge applications 

End Use Products Intended for Laundry Detergent This use has been voluntarily cancelled End Use Products Intended for General Purpose Cleaner 

Product application rate MUST be reduced to 72 ppm

End Use Products Intended for Wall Paper Adhesive 

Product application rate MUST be reduced to 67 ppm

32 of 87 
FORMALDEHYDE

Description Amended Labeling Language 

End Use Products Intended for Occupational use 

In order to reduce potential occupational handler exposures the following mitigation is required: 

• For industrial uses of formaldehyde close systems with dry couplers (or 

equivilant) are required 

• Structures that may be fumigated are limited to animal premises such as 

poultry houses and swine houses, mushroom houses, citrus packing houses, egg facilities and rail cars (not in-transit). 

• All fumugiated uses must be done in such a way that the operator is 

outside the structure undergoing fumigation when applying the fog.

• The labels must be updated to eliminate cloth or mop applications of 

formaldehyde. 

• Manual spray applications of formaldehyde solutions require the use of 

a full face respirator. 

• After fumigation poultry/swine containment building, re-entry by 

unprotected persons should be allowed only after a total 12 air changes. (e.g. 3 hours of ventilation at a rate of 4 air changes per hour ( ACH)) 

PARAFORMALDEHYDE 

Description Amended Labeling Language 

All End Use Products

End-Use Products for Vacation Homes ALL labels must limit the use to an UNOCCUPIED structure that can be 

thoroughly ventilated six (6) hours prior to re-occupancy. 

33 of 87 
34 of 87 

FORMALDEHYDE

Description Amended Labeling Language 

End-Use Products for BeautySalons and Barber Shops 

This product must be used in areas with general ventilation that meets ASHRAE recommendations and/or local exhaust ventilation that meets ACGIH recommendations.
35 of 87 

VI. APPENDICES 
Appendix A: Use Patterns Eligible for Reregistration for Formaldehyde (Case 0556)

Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

Agricultural premises and equipment Poultry and Turkey farms, Swine operations, Dairy farms, Cattle farms, Veal farms, Emu and ostrich farms 

Soluble concentrate: Reg: 134-65 Reg: 8133-33 

Spray or soak or fog 

1 - 3 oz of product per gallon of water. ONLY FOUND directions using 3 oz for canine and feline (not those listed to the left under use site) Preclean all surfaces. Spray all surfaces to saturation. 10minute contact time. 

Ventilate closed spacelivestock until treatmenor dried and all surfacescrubbed with soap or rinsed with potable waReentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of 

1 1⁄4 - 2 1⁄2 oz of product LESS than 0.75 ppm. per gallon of water. Wet mist until the area is moist using an approved automatic wet fogger. 

Federally inspected meat and poultry establishments exceptwhere meat and food products are handled. 

Soluble concentrate: Reg: 134-65 Reg: 8133-33 

Spray or soak or fog 

1 - 3 oz of product per gallon of water. ONLY FOUND directions using 3 oz for canine and feline (not those listed to the left under use site) Preclean all surfaces. Spray all surfaces to saturation. 10minute contact time. 

Ventilate closed spacelivestock until treatmenor dried and all surfacescrubbed with soap or rinsed with potable waReentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of LESS than 0.75 ppm. 

36 of 87 
Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

1 1⁄4 - 2 1⁄2 oz of product per gallon of water. Wet mist until the area is moist using an approved automatic wet fogger. 

Poultry and swine premises and confinement areas 

Soluble concentrate: Reg: 8133-32 Reg: 8133-33 

Mechanical sprayer orsprinkler 

Remove all animals. Preclean and sanitize the premises. Use 20-60 oz. of product for each 1000 ft3 of building volume. Sprinkler application: Use a 1:11 dilution in an approved sprinkler system. Follow approved application methods. Spray Sled: Use a 1:4 dilution in an approved portable spray sled. Follow approved application methods. 

For effectiveness, relatshould be at least 70% temperature at least 70Reentry restrictions: Tmust be left closed, locagainst unauthorized eminimum of 24 hours. Entry into treated areas correctly equipped hanuntil the air concentratformaldehyde is LESS 

Hatching egg washing/fumigating treatment 

Ready to Use: Reg: 8133-32 Reg: 8133-33 

Fog, fumigation 

Maximum of 2 fl. oz. per 1,000 eggs in a 24-hour period. Product is to be place in an open container and allowed to evaporate or in a slight vacuum. Do not use potassiumpermanganate as a catalyst. Repeated at a 

Incubators must be ven(“directly” has been relabel) to outside air. Fuperformed on both empand incubators containto be fumigated should racks or egg flats whiccirculation. Egg fumigNOT be done between 

37 of 87 
Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

maximum rate of 2 fl. oz. of Formaldehyde Solution 37 per 1,000 eggs in a 24-hour period. 

five days incubation bedamage may occur. Lashould be added at leasbefore chicks are pullerestrictions: Entry into other than correctly eqprohibited until the air level of formaldehyde 0.75 ppm.

Citrus packing houses Soluble 

concentrate: 

Reg: 8133-32 Reg: 8133-33 

Fog, fumigation 

Use 16 fl. Oz. of product per 1000 ft3 of space to betreated. Product may be diluted at a rate of up to one part solution to 10 parts water. Room to be treated should be tightly closed and humidity introduced for at least 24hours. Do not wet down with hose. Apply using an approved stationary mounted spray manifold and suitable air operated foggers. Premises may be treated up to twice a year. 

Worker buffer zone: Eworker buffer zone of residential buffer zone treated building during aeration. See buffer zodistributor. Buffer zonmaintained for 24 hourReentry restrictions: Tmust be left closed, locagainst unauthorized eminimum of 24 hours. Entry into treated areas correctly equipped hanuntil the air concentratformaldehyde is LESS Formaldehyde is phytoRemove all fruit from treated. Allow formalddissipate from storage filling with fruit. 

38 of 87 
Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

Iris and daffodil bulbs in bulb farms 

Soluble concentrate: Reg: 8133-33 

None listed on label 

None listed on label None 

Mushroom houses, equipment and premises 

Ready to Use: Reg: 8133-32 Reg: 8133-33 

Fog, fumigation 

Non Producing areas: Empty mushroom house of all growing media. Broom clean. Wet out growing boards. Close and seal up area to be treated. Inject steam into house until interior temperature reads 140-150F. Inject solution into steam (4 gallons for houses up to 26,600 ft3, 5 gallons in houses up to 33,300 ft3 and 8 gallons for houses up to 44,400 ft3) and continue steaming for 12 hours. Turn on exhaust fan for 12 hours, then ventilate for 24 hours. 

Reentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of LESS than 0.75 ppm. Reentry restrictions: Tmust be left closed, locagainst unauthorized eminimum of 24 hours. Entry into treated areas correctly equipped hanuntil the air concentratformaldehyde is LESS 

Commercial, institutional and industrial premises and equipment

39 of 87 
Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

Hard non-porous surfaces Soluble 

concentrate: 

Reg: 134-65 Reg: 8133-33 

Spray or soak or fog 

1 - 3 oz of product per gallon of water. Preclean all surfaces. Spray all surfaces to saturation. 10minute contact time. 

Ventilate closed spacelivestock until treatmenor dried and all surfacescrubbed with soap or rinsed with potable waReentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of LESS than 0.75 ppm. 

1 1⁄4 - 2 1⁄2 oz of product per gallon of water. Wet mist until the area is moist using an approved automatic wet fogger. 

Rooms and Railway cars Ready to 

Use: Reg: 8133-32 

Reg: 8133-33 

Fog, fumigation 

For each 1000 cubic feet of space, use 16 2/3 oz potassium permanganate and 20 oz of product. Place large dishpan on floor in which a smaller pan is set. Put Kpermanganate in the smaller pan and pour product over it. Leave room immediately. Close all windows and doors. Ventilate after 5 hours. 

Reentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of LESS than 0.75 ppm. 

Residential and public access premises 

40 of 87 
Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

Zoos Soluble 

concentrate: 

Reg: 134-65 

Spray, soak, mop or sponge 

1 oz of product per gallon of water. Preclean all surfaces. Spray all surfaces to saturation. 10minute contact time. Use at 3 oz per gallon to disinfect against canine parvovirus and feline panleukopenia. 

Ventilate closed spacelivestock until treatmenor dried and all surfacescrubbed with soap or rinsed with potable waReentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of LESS than 0.75 ppm. 

Veterinary clinics, kennels 

Soluble concentrate: Reg: 134-65 

Spray, soak, mop or sponge 

1 oz of product per gallon of water. Preclean all surfaces. Spray all surfaces to saturation. 10minute contact time. Use at 3 oz per gallon to disinfect against canine parvovirus and feline panleukopenia. 

Ventilate closed spacelivestock until treatmenor dried and all surfacescrubbed with soap or rinsed with potable waReentry restrictions: Eareas by other than corhandler is prohibited uconcentration level of LESS than 0.75 ppm. 

Pet shops Soluble Spray, soak, 1 oz of product per gallon Ventilate closed space

41 of 87 
Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use Limita

concentrate: Reg: 134-65 

mop or sponge 

of water. Preclean all surfaces. Spray all surfaces to saturation. 10minute contact time. Use at 3 oz per gallon to disinfect against canine parvovirus and feline panleukopenia 

livestock until treatmenor dried and all surfacescrubbed with soap or rinsed with potable waReentry restrictions: Entry into treated areas correctly equipped hanuntil the air concentratformaldehyde is LESS 

Industrial processes and water systemsOil recovery injection water systems 

Ready to Use: Reg: 8133-28 Reg: 8133-30 Reg: 10707-43 

Injection Inject in either a 

continuous treatment or slug application to produce between 25-5000 ppm of active ingredient. 

For use with closed deonly 

Drilling muds, work over fluids and water based packer fluids 

Ready to Use:  Reg: 8133-28 Reg: 8133-30 Reg: 10707-43 

Injection Inject in either a 

continuous treatment or slug application to produce between 100-500 ppm of active ingredient. 

For use with closed deonly 

Materials preservative Polishes for floors and furniture, surfactants and silicone emulsions 

Ready to use: 8133-32 

Incorporation Use range = 0.10 to 1000 

ppm in final product 

Solution may not be ucoming in direct conta/ or drinking water 

42 of 87 
Appendix A: Use Patterns Eligible for Reregistration 

Paraformaldahyde case number: (0556) 

Use Site Formulation Method of 

Application

Application Rate/ No. of 

applications 

Use L

Residential and public access premises SanitizerHair/beauty salons, and barber shops, sanitizer, cabinets, implement drawers, roller trays,student implement kits, covers ordoors of which are to be kept tightly closed.

Ready to use Reg 397-6 

Fumigant Remove cap place in sanitizer

cabinets

When fungicidal action is required keep closed for 24 hours. For use inhair. beauty salons and barber shops 

None mentioned 

43 of 87 
`APPENDIX B: Formaldahyde / Paraformaldahyde (case 0556 )

Appendix B lists the generic (not product specific) data requirements which support the re-registration of FormaParaformaldahyde. These requirements apply to Formaldahyde / Paraformaldahyde in all products, including dawhich a technical grade active ingredient is the test substance. 

DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

PRODUCT CHEMISTRY

830.1550 61-1 Product identity and composition 43987201, 43830.1600 830.1620 830.1650 

61-2a 

Starting Materials and Manufacturing Process 42724601, 43

830.1670 61-2b Formation of Impurities 42724601, 439830.1700 62-1 Preliminary Analysis 42724601, 43

43983801

830.1750 62-2 Certification of Limits 42724601, 43830.1800 62-3 Analytical Method 42724601, 43830.6302 63-2 Color 42724601, 43

57014, 57022

830.6303 63-3 Physical State 42724601, 43

57014, 57022

830.6304 63-4 Odor 42724601, 43

57014, 57022

830.7200 63-5 Melting point 43987201, 43

76242 

830.7300 63-7 Density or Specific Gravity 43987201, 43

57024, 76242

830.7840 830.7860 

63-8 

Solubility 

42724601, 570

44 of 87 
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

830.7950 63-9 Vapor pressure 42724601, 43

124869, 57014

830.7370 63-10 Dissociation Constant 42930901, 43830.7550 63-11 Oct/Water partition Coef 42930901, 43830.7000 63-12 pH 42930901, 43830.6313 63-13 Stability 

42930901, 4357014, 57024

830.6315 63-15 Flammability 43987201, 43830.6316 63-16 Explodability 43987201, 43830.6315 63-17 Storage Stability 43987201, 439830.7100 63-18 Viscosity 43987201, 43830.7100 63-19 Miscibilty 43987201, 43830.6320 63-20 Corrosion Characteristic 43987201, 439830.6321 63-21 Dielectric Breakdown Voltage 43987201, 43830.6314 63-14 Oxidation/Reduction: Chemical Incompatibility 43987201, 43870.1100 81-1 Acute Oral - Rat 00058054, 000870.1200 81-2 Acute Dermal - Rabbit 00058054, 000870.1300 81-3 Acute Inhalation - Rat Open Literatu870.2500 81-5 Primary Dermal Irritation - Rabbit 00058054, 000870.2600 81-6 Dermal Sensitization 40161103, Op870.3100 82-1a 90-Day Feeding-Rodent 00124677, 00870-3150 82-1 90 Day oral toxicity in norodents Open Literatu

45 of 87 
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

870.3250 82-3 90-Day Dermal Toxicity-Rodent Data Gap 870-3465 82-4 90 Day inhalation toxicity 00082134. Op870.3465 82-4 6 week inhalation toxcity 00149755 870.3700 83-3a Developmental Toxicity -Rat

00082136, 0000164652, Op

870.3700 83-3b Developmental Toxicity –Non rodent Data Gap 870.3800 83-4 Reproduction and fertility effects 00143291, Op870.4100 83-1a Chronic Toxicity-Rat Open Literatu870.4200 83-2a Carcinogenicity-Rat 00143288, Op870.4200 83-2b Carcinogenicity-Mouse Open Literatu870.4300 83-5 Combined chronic toxicity/ Carcinogenicity 00143289870.5100 84-2 Bacterial Reverse Mutation Assay 00132156, 00870-5200 84-2 Mouse visible specific locus test Open Literatu870-5275 Sex- linked recessive lethal test in Dorosophlia melanogaster Open Literatu870.5375 84-2 In Vitro mammalian chromosome aberration test 00132168, Op870.5380 84-2 Mammalian spermatogonial chromosome aberration test Open Literatu870-5450 84-2 Rodent dominant lethal assay Open Literatu870.5550 84-2 Unscheduled DNA synthesis in mammalian cell culture 00132169 870.5900 84-2 In Vitro sister chromatid exchange assay Open Literatu870.5915 84-2 In Vitro sister chromatid exchange assay Open Literatu870.6200 82-7 Neurotoxicity screening battery Open literatur

46 of 87 
47 of 87 

DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

870.6500 85-5 Schedule-controlled operant behavior Open Literatu870.7485 85-1 General metabolism Open Literatu
Appendix C. Technical Support Documents 

Additional documentation in support of this RED is maintained in the OPP 

docket, located in Room 119, Crystal Mall #2, 1801 Bell Street, Arlington, VA. It is open 

Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm. 

OPP public docket is located in Room S-4400, One Potomac Yard (South Building), 

2777 South Crystal Drive, Arlington, VA, 22202 and is open Monday through Friday, 

excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. 

The docket initially contained the (date) preliminary risk assessment and the 

related documents. EPA then considered comments on these risk assessments (which are 

posted to the e-docket) and revised the risk assessments. The revised risk assessments 

will be posted in the docket at the same time as the RED. 

All documents, in hard copy form, may be viewed in the OPP docket room or 

downloaded or viewed via the Internet at www.regulations.gov

These documents include: 

• Formaldehyde Preliminary Risk Assessment; Notice of Availability, (date). 

• Formaldehyde Summary, (date). 

• Overview of the Formaldehyde Preliminary Risk Assessment, (date). 

Preliminary Risk Assessment and Supporting Science Documents: 

• Formaldehyde: Preliminary Risk Assessment for the Reregistration Eligibility 

Decision, PC Code 043001, Case 0556, Antimicrobials Division, 4/7/08, 

Timothy F. McMahon, Ph.D., Jonathan Chen, Ph.D., Srivivas Gowda, Ph.D., A. 

Najm Shamim, Ph.D., Richard C. Petrie, Agronomist, Timothy C. Dole, CIH, 

Industrial Hygienist. 

• Product Chemistry Science Chapter on Formaldehyde. PC Code 043001, Case 

0556, Antimicrobials Division, 1/24/08, Srivivas Gowda, Ph.D. 

• Product Chemistry Science Chapter on Paraformaldehyde. PC Code 043002, Case 

0556, 

 Antimicrobials Division, 1/24/08, Srivivas Gowda, Ph.D. 

• Formaldehyde: Toxicology Disciplinary Chapter for the Reregistration Eligibility 

Decision Document, PC Code 043001, Case 0556, Antimicrobials Division, 

3/31/08, Timothy F. McMahon, Ph.D. 

• Formaldehyde Dietary Exposure Assessments for the Reregistration Eligibility 

Decision. PC Code 043001, Case 0556, Antimicrobials Division, 1/29/08, A. 

Najm Shamim, Ph.D. 

• Formaldehyde Occupational/Residential Exposure Assessment. PC Code 043001, 

Case 0556, Antimicrobials Division, 4/15/08, Timothy C. Dole, CIH, Industrial 

Hygienist. 

• Health Effects of Formaldehyde in Humans. PC Code 043001, Case 0556, 

Antimicrobials Division, 1/30/08. 

48 of 87 
• Environmental Fate Assessment of Formaldehyde for the Reregistration 

Eligibility Decision (RED). PC Code 043001, Case 0556, Antimicrobials 

Division, 1/23/08, A. Najm Shamim, Ph.D. 

• Ecological Hazard and Environmental Risk Assessment: Formaldehyde. PC Code 

043001, Case 0556, Antimicrobials Division, Richard C. Petrie, Agronomist. 

• Drinking Water Assessment for Formaldehyde Reregistration Eligibility Decision 

(RED). PC Code 043001, Case 0556, Antimicrobials Division, 1/30/08 A. Najm

Shamim, Ph.D. 

• Formaldehyde/Paraformadehyde - Report of the Antimicrobials Division Toxicity 

Endpoint Selection Committee (ADTC). PC Code 043001; 043002, Case 0556, 

Antimicrobials Division, Timothy F. McMahon, Ph.D. 

49 of 87 
Appendix D. Citations Considered to be Part of the Data Base Supporting the 

Reregistration Decision (Bibliography) 

GUIDE TO APPENDIX D

1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all 

studies considered relevant by EPA in arriving at the positions and conclusions stated 

elsewhere in the Chlorine Dioxide Reregistration Eligibility Document. Primary sources 

for studies in this bibliography have been the body of data submitted to EPA and its 

predecessor agencies in support of past regulatory decisions. Selections from other 

sources including the published literature, in those instances where they have been 

considered, are included.

2. UNITS OF ENTRY. The unit of entry in this bibliography is called a “study.” In 

the case of published materials, this corresponds closely to an article. In the case of 

unpublished materials submitted to the Agency, the Agency has sought to identify 

documents at a level parallel to the published article from within the typically larger

volumes in which they were submitted. The resulting “studies” generally have a distinct 

title (or at least a single subject), can stand alone for purposes of review and can be 

described with a conventional bibliographic citation. The Agency has also attempted to 

unite basic documents and commentaries upon them, treating them as a single study. 

3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted 

numerically by Master Record Identifier, or “MRID” number. This number is unique to 

the citation, and should be used whenever a specific reference is required. It is not 

related to the six-digit “Accession Number” which has been used to identify volumes of 

submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases, 

entries added to the bibliography late in the review may be preceded by a nine character 

temporary identifier. These entries are listed after all MRID entries. This temporary 

identifying number is also to be used whenever specific reference is needed. 

4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each 

entry consists of a citation containing standard elements followed, in the case of material 

submitted to EPA, by a description of the earliest known submission. Bibliographic 

conventions used reflect the standard of the American National Standards Institute 

(ANSI), expanded to provide for certain special needs. 

a. Author. Whenever the author could confidently be identified, the Agency

has chosen to show a personal author. When no individual was identified, the Agency 

has shown an identifiable laboratory or testing facility as the author. When no author or 

laboratory could be identified, the Agency has shown the first submitter as the author. 

b. Document date. The date of the study is taken directly from the 

document. When the date is followed by a question mark, the bibliographer has deduced 

the date from the evidence contained in the document. When the date appears as (1999), 

the Agency was unable to determine or estimate the date of the document. 

50 of 87 
c. Title. In some cases, it has been necessary for the Agency bibliographers

to create or enhance a document title. Any such editorial insertions are contained 

between square brackets.

d. Trailing parentheses. For studies submitted to the Agency in the past, the 

trailing parentheses include (in addition to any self-explanatory text) the following 

elements describing the earliest known submission: 

(1) Submission date. The date of the earliest known submission appears immediately 

following the word “received.” 

(2) Administrative number. The next element immediately following the word

“under” is the registration number, experimental use permit number, petition number, or 

other administrative number associated with the earliest known submission. 

(3) Submitter. The third element is the submitter. When authorship is defaulted to 

the submitter, this element is omitted.

(4) Volume Identification (Accession Numbers). The final element in the trailing 

parentheses identifies the EPA accession number of the volume in which the original 

submission of the study appears. The six-digit accession number follows the symbol 

“CDL,” which stands for “Company Data Library.” This accession number is in turn 

followed by an alphabetic suffix which shows the relative position of the study within the 

volume.

51 of 87 
1. MRID Studies 

MRID # Citation

00065640 Birdsong, C. L. and J.W. Avalt, Jr. (1971). Toxicity of Certain Chemicals 

to Juvenile Pompano. Progressive Fish Culturist.33:76-80. 

00101857 Bentley, R.E. (1975). Acute Toxicity of Ten Baroid Compounds to Bluegill (Lepomis macrochirus) 

and Rainbow Trout (Salmo gairdneri). Unpublished study. Conducted by Bionomics, EG&G for 

Baroid, Division, N.L. Industries, Houston, TX. 

 00126394 Heitmuller, T. (1975). Acute Toxicity of Surflo-B17 to Larvae of the 

Eastern Oyster ..., Pink Shrimp ..., and Fiddler Crabs (Uca pugilator). 

Unpublished study. Conducted by Bionomics, EG&G for Baroid Division, 

N. L. Industries, Houston, TX. 

00126395 Heitmuller, T. (1975). Acute Toxicity of Aldacide to Larvae of the Eastern Oyster .., Pink Shrimp 

..., and Fiddler Crabs (Uca pugilator). Unpublished study. Conducted by Bionomics, EG&G for

Baroid Division, N. L. Industries, Houston, TX. 

00126396 Heitmuller, T. (1975). Acute Toxicity of Surflo-B19 to Larvae of the Eastern Oyster ..., Pink 

Shrimp ..., and Fiddler Crabs (Uca pugilator). Unpublished study. Conducted by Bionomics, 

EG&G for Baroid Division, N. L. Industries, Houston, TX. 

00128086 Heitmuller, T. (1975). Acute Toxicity of Surflo-B16 to Larvae of the Eastern Oyster ..., Pink 

shrimp ..., and Fiddler Crabs (Uca pugilator). Unpublished study. Conducted by Bionomics, 

EG&G for Baroid Division, N. L. Industries, Houston TX. 

00132485 Bills, T.D., Marking, L.L., and J.H. Chandler. (1977). Formalin: Its Toxicity to Nontarget Aquatic 

Organisms, Persistence, and Counteraction. U.S. Fish & Wildlife Service, Invest. Fish Control 

73:1-7. 

00134123 McCann, J. and F. Pitcher. (1973). Russell’s Incubator Fumigant: Bluegill: Test No. 577. 

Unpublished study. Prepared by Pesticides Regulation Division, Animal Biology Laboratory, U.S. 

Environmental Protection Agency, Beltsville, MD. 

00134124 McCann, J., and F. Pitcher. (1973). Russell’s Incubator Fumigant: Rainbow Trout: Test No. 560. 

Unpublished study. Prepared by Pesticides Regulation Division, Animal Biology Laboratory, U.S. 

Environmental Protection Agency, Beltsville, MD. 

00134126 McCann, J. and F. Pitcher. (1973). Parson’s Formaldehyde: Bluegill: Test No. 594. Unpublished 

study. Prepared by Pesticides Regulation Division, Animal Biology Laboratory, U.S. 

Environmental Protection Agency, Beltsville MD. 

00148770 Lemon, K.A. (1985). Acute Toxicological Evaluations of Estuarine 

Organisms to Support Registration Action 44797-RL. Conducted by 

EnviroSystems, Inc. for N.L. Treating Chemical Company, Houston, TX. . 

 00148772 Smith, E.H. (1985). Acute Toxicity of Formalin on Daphnia magna to 

Support Registration Action 44797-RL. Unpublished study. Conducted by 

ANATEC Laboratories, Inc. for N.L. Testing Chemicals, Houston TX. 

52 of 87 
00148773 Fletcher, D.W. (1983). Report to NL Treating Chemicals/NL Industries, 

Inc., Eight-day Dietary LC50 Study with Surflo-B315 in Bobwhite Quail: 

BLAL No.83 QC 39. Unpublished study. Conducted by Bio-Life 

Associates Ltd. For NL Treating Chemicals/NL Industries, Inc. 

 00148774 Fletcher, D.W. (1983). Report to NL Treating Chemicals, NL Industries, 

Inc., Acute Toxicity Study with Surflo-B315 in Bobwhite Quail: BLAL 

No.83 QD 38. Unpublished study Conducted by Bio-Life Associates Ltd. 

For NL Treating Chemicals/NL Industries, Inc. 

 00148775 Fletcher, D.W. (1984). Report to NL Treating Chemicals, NL Industries, 

Inc., Eight-day Dietary LC50 Study with Surflo-B315 in Mallard 

Ducklings: BLAL No.83 DC 40. Unpublished study. Conducted by BioLife Associates Ltd. For NL Treating Chemicals/NL Industries, Inc. 

00058054 Celanese Chemical Company (1976?) Toxicological Data and Health 

Hazards: Formaldehyde. (Unpublished study received Nov 4, 1977 under 

11558-8; CDL: 232282-K) 

00065508 3T1522: Laboratory Nos. 5E-6921, 5E-6923, 5E-6924, 5E- 6922. 

(Unpublished study received Jan 11, 1977 under 10000-4; submitted by 

Hallemite Lehn & Fink, Montvale, N.J.; CDL: 229296-A) 

00065514 St. Pierre, F.; Parke, G.S.E. (1976) Report on Primary Dermal Irritation 

Study in Rabbits: Laboratory No. 6E-4231. (Unpublished study received 

Jan 11, 1977 under 10000-4; prepared by Cannon Laboratories, Inc., 

submitted by Hallemite Lehn & Fink, Mont- vale, N.J.; CDL:229296-G) 

00082134 Coon, R.A. et al. (1970) Animal Inhalation Studies on Ammonia, Ethylene 

Glycol, Formaldehyde, Dimethylamine, and Ethanol. Toxicology and 

Applied Pharmacology 16: 646-655. 

00082136 Schnurer, L.B. (1963) Maternal and foetal responses to chronic stress in 

pregnancy: A study in albino rats. Acta Endocrinologica, Supplement 80 

?:3-96. (Also in unpublished submission received Oct 15, 1973 under 

4G1438; submitted by Chevron Chemical Co., Richmond, Calif.; 

CDL:095383-A) 

00123769 Ranstrom, S. and Schrurer, L. (1956) Stress and Pregnancy. Acta Pathol. 

Microbiol. Scandinavia. Supplement III, 113-114.

00123770 Schnurer, L. (1963) Maternal and foetal responses to chronic stress in 

pregnancy. Acta Endocrinologica (80):3-96. (Also In unpublished 

submission received 1963 under 4G1438; submitted by Chevron Chemical 

Co., Richmond, CA; CDL:093832-T)

53 of 87 
00124677 Driedger, A.; Walker, J.; Galloway, F. (1973) Letter sent to C. Smart 

dated Oct 1, 1973: “Rat tolerance to Dietary Formaldehyde: Reference No. 

AD-114-73, JRW-341-73.” (Unpublished study; submitted by Celanese 

Chemical Co., Dallas, TX; CDL:094622-H)

00132156 Jagannath, D. (1978) Mutagenicity Evaluation of Dantoin DMDMH-55 

40-697 737543 in the Ames Salmonella/Microsome Plate Test: LBI 

Project No. 20838. Final rept. (Unpublished study received May 9, 1983 

under 38906-5; prepared by Litton Bionetics, Inc., sub- mitted by Glyco, 

Inc., Greenwich, CT; CDL:250313-A)

00132157 Haworth, S.; Lawlor, T.; Burke, P.; et al. (1982). Salmonella/Mammalianmicrosome Preincubation Mutagenicity Assay (Ames Test): Test Article 

447:34-3: Study No. T1804.502. (Unpublished study received May 9, 

1983 under 38906-5; prepared by Microbiological Assoc., submitted by 

Glyco, Inc., Greenwich, CT; CDL:250313-B). 

00132168 Thilagar, A.; Kumaroo, P.; Pant, K. (1982) Cytogenicity Study: Chinese 

Hamster Ovary (CHO) Cells in vitro: Test Article 447:34-1: Study No. 

T1802.338. (Unpublished study received May 9, 1983 under 38906-5; 

prepared by Microbiological Assoc., submitted by Glyco, Inc., Greenwich, 

CT; CDL:250313-M)

00132169 Thilagar, A.; Pant, K. (1982) Unscheduled DNA Synthesis in Rat 

Hepatocytes: Test Article 447:34-1: Study No. T1802.380002. (Unpublished study received May 9, 1983 under 38906-5; prepared by 

Microbiological Assoc., submitted by Glyco, Inc., Greenwich, CT; 

CDL:250313-N)

00134114 Viguera, C.; Kundzins, M. (1960) “28-Day Oral Administration--Rats: 

U.F. Concentrate-85|.” (Unpublished study; prepared by Hazleton 

Laboratories, Inc.; CDL: 105284-C)

00143288 Watanabe, F., et al. (1954) Study on the Carcinogenicity of 

Aldehyde. 1st Report. Experimentally Produced Rat Sarcomas by 

Repeated Injections of Aqueous Solution of Formaldehyde. Two 

unpublished translations of Japanese article published in Gann 45(2-

3):451-452.

00143289 Kerns, W.D. et al. (1983) Carcinogenicity of Formaldehyde in Rats 

and Mice after Long-Term Inhalation Exposure. Cancer Research 43: 

4382-4392. 

00143291 Hurni, H. and H. Odher (1972) Reproduction Study with Formaldehyde 

and Hexamethylenetetr-amine in Beagle Dogs. Fd. Cosmet. Toxicol. 11: 

459-462.

54 of 87 
00149755 Rusch, G.; Rinehart, W. (1980) A 26 Week Inhalation Toxicity Study of 

Formaldehyde in Monkey, Rat, and Hamster: Project No. 79- 7259. 

Unpublished study prepared by Bio/dynamics Inc. 184 p.

00159392 Liggett, M.; Wilson, J. (1980) Irritant Effects of Acticide BG on Rabbit 

Skin: 79648D/THR 2. Unpublished study prepared by Huntingdon 

Research Centre. 5 p.

00159393 Liggett, M.; Wilson, J. (1980) Irritant Effects of Acticide BG on 

Rabbit Eye Mucosa: 8088D/THR3. Unpublished study prepared by 

Huntingdon Research Centre. 5 p.

00159395 Kynoch, S.; Charnley, B.; Ginty, J. (1980) Acute Percutaneous Toxicity to 

Rats of Acticide BG: 79625D/THR4. Unpublished study prepared by 

Huntingdon Research Centre. 5 p. 

00164652 Marks, Thomas A. et al. (1980) Influence of Formaldehyde and Sonacide 

(Potentiated Acid Glutaraldehyde) on Embryo and Fetal Development in 

Mice. Teratology 22: 51-58. 

40161103 Spiers, J. (1987) Formaldehyde: Skin Sensitisation Study to the 

Guinea Pig: (Positive Control): Laboratory Project ID: CTL/P/ 1211A. 

Unpublished study prepared by ICI Central Toxicology Laboratory. 28 p. 

43167201 Burleigh- Flayer, H. D. and W.J. Kintigh (1992) Glutaraldehyde and 

Formaldehyde: Vapor Pulmonary Hypersensitivity Study in Guinea Pigs. 

Bushy Run Research Center (Export, PA), Union Carbide. Study ID 

92U1123, dated February 28, 1992, Unpublished. 

43170601 Werley et al. (1994). Glutardehyde and Formaldehyde: Sensory 

Irritation Study in Swiss-Webster Mice. Union Carbide Lab Project No. 

91U0123. 

00146665 Celanese Chemical Co., Inc. (1985) [Product Chemistry: Formaldehyde 

45%]. Unpublished compilation. 19 p. 

41926001 Sibinovic, K. (1991) Reichold Formaldehyde/ Methanol: Product 

Chemistry: Accelerated Storage Stability: Lab Project Number: C80- PCRI-1991. Unpublished study prepared by Shaldra, Inc. 38 p. 

42596708 Stupp, S. (1992) Product Chemistries and 30-Day Storage Stability of 

Methaform 55A: (Product renamed Formaldehyde Solution 54): Lab 

Project Number: CHAMP-01A-92. Unpublished study prepared by A & S 

Environmental Testing, Inc. 65 p. 

55 of 87 
42656801 Petrolite Corp. (1993) Formaldehyde: Physical and Chemical 

Characteristics. Unpublished study. 4 p. 

42724601 Stupp, S. (1992) Product Chemistries and 30-Day Storage Stability of 

Methaform 55A: (Product renamed Formaldehyde Solution 54): Lab 

Project Number: CHAMP-01A-92. Unpublished study prepared by A & S 

Environmental Testing, Inc. 65 p. 

42859001 Stupp, S. (1991) Product Chemistry and 30-Day Storage Stability of 

Bactron K-55W Microbiocide: Lab Project Number: C80-BACT55-PC1990: C80-ASST-PC-1991. Unpublished study prepared by A & S 

Environmental Testing, Inc. 75 p. 

42995401 Stupp, S. (1993) Product Chemistries and 30 Day Storage Stability of 

Formaldehyde Solution 54: Lab Project Number: CHAMP-01A-92. 

Unpublished study prepared by A&S Environmental Testing, Inc. 172 p. 

42930901 Stupp, S. (1992) Product Chemistries and 30 Day Storage Stability of 

Formaldehyde Solution 54: Lab Project Number: CHAMP-01A-92. 

Unpublished study prepared by A & S Environmental Testing, Inc. 65 p. 

43051601 Douglas, C. (1993) Formaldehyde-Product Identity Analysis and 

Certification of Product Ingredients. Unpublished study prepared by 

Borden Packaging and Industrial Products. 51 p.

43745001 Sibinovic, K.; Tenhaeff, S. (1995) Product Chemistry--Formaldehyde 

Solution 37: Lab Project Number: BORDEN-FS97-95. Unpublished study 

prepared by Shaldra, Inc. and Borden Chemical & Plastics. 35 p. 

44952301 Sibinovic, K. (1999) Product Chemistry--Formaldehyde Solution 37F: Lab 

Project Number: CTI-99-PC-01. Unpublished study prepared by Shaldra, 

Inc. 31 p.

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Gulf of Mexico OCS Region, New Orleans, L.A. OCS Study MMS 2000-064. 

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Chenier, R. (2003). An Ecological Risk Assessment of Formaldehyde. Human and 

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Acrolein During Single and Repeated Exposures in Mice. American Industrial 

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Kimbell JS, Overton JH, Subramaniam RP, Schlosser PM, Morgan KT, Conolly RB, 

Miller FJ. (2001): Dosimetry modeling of inhaled formaldehyde: binning nasal 

flux predictions for quantitative risk assessment. Toxicol Sci. Nov;64(1):111-21. 

Kligerman, A.D., Phelps, M.C., Erexson, G.L. (1984). Cytogenetic analysis of 

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Krivanek, N.D., Chromey, N.C. and McAlack, J.W. (1983)."Skin initiation- promotion 

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Odeigah, P.G.C. (1997). “Sperm Head Abnormalities and Dominant Lethal Effects of 

Formaldehyde in Albino Rats.” Mutation Research 389: 141-148. 

O’Donovan, MR; Mee, CD. (1993) Formaldehyde is a bacterial mutagen in a range of 

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expression of Th1- and Th2-related cytokines in nasal mucosa after short-term

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animal experiments. Pathol Res Pract 196:193-198. 

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2. Website References 

Citation

Assessments of the reproductive and developmental toxicity of formaldehyde 

conducted by the Australian government (www.nicnas.gov.au) as well as the Agency 

for Toxic Substances and Disease Registry (ATSDR, 1999)support this conclusion. 

EPA is currently completing a new IRIS assessment that will include a cancer 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 =view 

Chemical.showChemical&sw_id=1031). EPA anticipates that the peer review of the

formaldehyde assessment will not be finished before EPA completes the 

reregistration process for formaldehyde pesticidal uses, scheduled to conclude in 

September 2008. 

The EPA’s Consumer Exposure Module (CEM) was used to estimate air 

concentrations resulting from the use of laundry detergent preserved with 

formaldehyde. Detailed information and the executable model can be downloaded 

from http://www.epa.gov/opptintr/exposure.

3. Other Supporting Documents 

Citation

ASHRAE, 1989. Ventilation for Acceptable Indoor Air Quality, American Society of 

Heating Refrigerating and Air Conditioning Engineers, 1989. 

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ASRC, 2005. Formaldehyde Smart Meeting, August 9, 2005, Minutes Prepared by Eric 

Brewer of ASRC Aerospace. 

Jacobson, Larry. 2005. Professor and Extension Engineer at University of Minnesota. 

Kline, 2000. Specialty Biocide North America 2000, Kline and Company, Inc. 

NIOSH, 1990. Health Hazard Evaluation of Buckeye Hills Career Center (HETA 88-153-

2072), NIOSH, October 1990. 

NIOSH, 1997. Pocket Guide to Chemical Hazards, DHHS (NIOSH Publication No. 97-

140) 

Olcrest, 1999. Paraformaldehyde Sterilant Use in Vocational High School Program, 

Robert Olcrest, Brujos Scientific Inc., Baltimore, Maryland. Published in Applied 

Occupational and Environmental Hygiene, Volume 14: 391-396, 1999 

USDA, 1999. Crop Profile for Poultry (Broilers) in California 

USDA, 2000. Crop Profile for Eggs in California 

USDA, 2002. Crop Profile for Poultry in Florida 

US EPA, 1997a. Exposure Factors Handbook. Volume I-II. Office of Research and 

Development. Washington, D.C. EPA/600/P-95/002Fa. 

US EPA, 1999. Evaluation of Chemical Manufacturers Association Antimicrobial 

Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., US EPA, to 

Julie Fairfax,

US EPA, 2008. Incident Reports Associated with Formaldehyde. Jonathen Chen Ph.D., 

US EPA, 2008. Formaldehyde - Report of the Antimicrobials Division Toxicity Endpoint 

Selection Committee (ADTC), 

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Appendix E. Generic Data Call-In 

The Agency intends to issue a Generic Data Call-In at a later date. See the Formaldahyde 

/ Paraformaldahyde RED for a list of studies that the Agency plans to require. 

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Appendix F. Product Specific Data Call-In 

The Agency intends to issue a Product Specific Data Call-In at a later date for: 

Formaldahyde / Paraformaldahyde ( 0556 ) 

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Appendix G. Batching of Formaldahyde / ParaformaldahydeProducts for Meeting 

Acute Toxicity Data Requirements for Reregistration 

The Agency intends to complete a Batching Memo at a later date 

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Appendix H. List of All Registrants Sent the Data Call-In 

The Agency intends to issue a Data Call-In at a later date to the following registrants: 

Baker Petrolite Corporation 

12645 West Port Airport Blvd 

Sugarland, Texas 77478 

Champion Technologies, Inc. 

3185 Madison Highway, PO Box 5126 

Valdosta Georgia 316035126 

Protexall Products, Inc. 

402 Integrated Court 

Debary, Florida 32713 

Noble Pine Products Co. 

PO Box 41 Centuck Stat 

Yonkers, New York, 10710 

Hess & Clark Inc. 

110 Hopkins Drive 

Randolph, Wisconsin 539561316 

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Appendix I. List of Available Related Documents and Electronically Available 

Forms 

Pesticide Registration Forms are available at the following EPA internet site: 

http://www.epa.gov/opprd001/forms/ . 

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions 

1. Print out and complete the forms. (Note: Form numbers that are bolded can be 

filled out on your computer then printed.) 

2. The completed form(s) should be submitted in hardcopy in accord with the 

existing policy. 

3. Mail the forms, along with any additional documents necessary to comply with 

EPA regulations covering your request, to the address below for the Document 

Processing Desk. 

DO NOT fax or e-mail any form containing ‘Confidential Business Information’ or 

‘Sensitive Information.’ 

If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-

5551 or by e-mail at williams.nicole@epamail.epa.gov. 

The following Agency Pesticide Registration Forms are currently available via the 

internet at the following locations: 

8570-1 Application for Pesticide Registration/Amendment http://www.epa.gov/opprd001/forms/8570-1.pdf

8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf

8570-5 Notice of Supplemental Registration of Distribution of

a Registered Pesticide Product 

http://www.epa.gov/opprd001/forms/8570-5.pdf

8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf

8570-25 Application for/Notification of State Registration of a 

Pesticide To Meet a Special Local Need

http://www.epa.gov/opprd001/forms/8570-25.pdf

8570-27 Formulator’s Exemption Statement http://www.epa.gov/opprd001/forms/8570-27.pdf

8570-28 Certification of Compliance with Data Gap Procedures http://www.epa.gov/opprd001/forms/8570-28.pdf

8570-30 Pesticide Registration Maintenance Fee Filing http://www.epa.gov/opprd001/forms/8570-30.pdf

8570-32 Certification of Attempt to Enter into an Agreement 

with other Registrants for Development of Data

http://www.epa.gov/opprd001/forms/8570-32.pdf

8570-34 Certification with Respect to Citations of Data (in PR 

Notice 98-5) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-

5.pdf

8570-35 Data Matrix (in PR Notice 98-5) http://www.epa.gov/opppmsd1/PR_Notices/pr98-

5.pdf

8570-36 Summary of the Physical/Chemical Properties (in PR

Notice 98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-

1.pdf

8570-37 Self-Certification Statement for the Physical/Chemical 

Properties (in PR Notice 98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-

1.pdf

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Pesticide Registration Kit

www.epa.gov/pesticides/registrationkit/. 

Dear Registrant: 

For your convenience, we have assembled an online registration kit that contains 

the following pertinent forms and information needed to register a pesticide product with 

the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP): 

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 

Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food 

Quality Protection Act (FQPA) of 1996. 

2. Pesticide Registration (PR) Notices 

 a. 83-3 Label Improvement Program—Storage and Disposal 

 Statements 

b. 84-1 Clarification of Label Improvement Program 

c. 86-5 Standard Format for Data Submitted under FIFRA 

d. 87-1 Label Improvement Program for Pesticides Applied through 

Irrigation Systems (Chemigation) 

e. 87-6 Inert Ingredients in Pesticide Products Policy Statement 

f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy 

 Statement 

g. 95-2 Notifications, Non-notifications, and Minor Formulation 

Amendments

h. 98-1 Self Certification of Product Chemistry Data with 

Attachments (This document is in PDF format and requires the 

Acrobat reader.) 

Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices. 

3. Pesticide Product Registration Application Forms (These forms are in 

PDF format and will require the Acrobat reader.)

a. EPA Form No. 8570-1, Application for Pesticide 

 Registration/Amendment 

b. EPA Form No. 8570-4, Confidential Statement of Formula 

c. EPA Form No. 8570-27, Formulator’s Exemption Statement 

d. EPA Form No. 8570-34, Certification with Respect to Citations of 

 Data

e. EPA Form No. 8570-35, Data Matrix 

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4. General Pesticide Information (Some of these forms are in PDF format 

and will require the Acrobat reader.)

a. Registration Division Personnel Contact List 

b. Biopesticides and Pollution Prevention Division (BPPD) Contacts 

 c. Antimicrobials Division Organizational Structure/Contact List 

d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data 

Requirements (PDF format) 

e. 40 CFR Part 156, Labeling Requirements for Pesticides and 

Devices (PDF format) 

f. 40 CFR Part 158,Data Requirements for Registration (PDF format) 

g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data 

(November 27, 1985) 

Before submitting your application for registration, you may wish to consult some

additional sources of information. These include: 

1. The Office of Pesticide Programs’ Web Site 

2. The booklet “General Information on Applying for Registration of 

Pesticides in the United States”, PB92-221811, available through the 

National Technical Information Service (NTIS) at the following address: 

National Technical Information Service (NTIS) 

 5285 Port Royal Road 

 Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000. Please note that EPA is 

currently in the process of updating this booklet to reflect the changes in the registration 

program resulting from the passage of the FQPA and the reorganization of the Office of 

Pesticide Programs. We anticipate that this publication will become available during the 

Fall of 1998. 

3. The National Pesticide Information Retrieval System (NPIRS) of Purdue 

University’s Center for Environmental and Regulatory Information 

Systems. This service does charge a fee for subscriptions and custom

searches. You can contact NPIRS by telephone at (765) 494-6614 or 

through their Web site. 

4. The National Pesticide Telecommunications Network (NPTN) can provide 

information on active ingredients, uses, toxicology, and chemistry of 

pesticides. You can contact NPTN by telephone at (800) 858-7378 or 

through their Web site: http://npic.orst.edu . 

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The Agency will return a notice of receipt of an application for registration or 

amended registration, experimental use permit, or amendment to a petition if the 

applicant or petitioner encloses with his submission a stamped, self-addressed postcard. 

The postcard must contain the following entries to be completed by OPP: 

 Date of receipt 

 EPA identifying number 

 Product Manager assignment 

Other identifying information may be included by the applicant to link the 

acknowledgment of receipt to the specific application submitted. EPA will stamp the 

date of receipt and provide the EPA identifying File Symbol or petition number for the 

new submission. The identifying number should be used whenever you contact the 

Agency concerning an application for registration, experimental use permit, or tolerance 

petition. 

To assist us in ensuring that all data you have submitted for the chemical are 

properly coded and assigned to your company, please include a list of all synonyms, 

common and trade names, company experimental codes, and other names which identify 

the chemical (including “blind” codes used when a sample was submitted for testing by

commercial or academic facilities). Please provide a CAS number if one has been 

assigned. 

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