A EPA
EPA Document #EPA-740-R-24-016
December 2024
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Conditions of Use of the
Risk Evaluation for Formaldehyde
CASRN 50-00-0
o
December 2024
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TABLE OF CONTENTS
1 INTRODUCTION 6
2 RISK EVALUATION SCOPE 7
2.1 Conditions of Use Included in the Risk Evaluation 7
2.1.1 Additions and Name Changes to Conditions of Use Based on Updated 2020 CDR
Reported Data 14
2.1.2 Additions and Name Changes to Conditions of Use Based on Public Comments Received
on the Draft Risk Evaluation 16
2.2 Activities Determined Not to Be Conditions of Use 17
2.2.1 Industries Affected by Activities Determined Not to Be Conditions of Use 19
2.2.2 Biogenic Sources of Formaldehyde Not Considered as Conditions of Use 20
2.3 Secondary Formation of Formaldehyde and Certain Combustion Sources 20
2.4 Additions to the Scope Pertaining to Exposure Pathways and Risks Addressed by Other
EPA-Administered Statutes 20
2.5 Clarification Regarding Consideration of Formalin and Paraformaldehyde in the Risk
Evaluation 22
3 REFERENCES 23
Appendix A DESCRIPTION OF CONDITIONS OF USE 29
A. 1 Manufacturing - Domestic Manufacturing 29
A.2 Manufacturing - Importing 29
A.3 Processing - Reactant - Adhesives and Sealant Chemicals in: Plastic and Resin
Manufacturing; Wood Product Manufacturing; Paint and Coating Manufacturing; Basic
Organic Chemical Manufacturing 30
A.4 Processing - Reactant - Intermediate in: Pesticide, Fertilizer, and Other Agricultural
Chemical Manufacturing; Petrochemical Manufacturing; Soap, Cleaning Compound, and
Toilet Preparation Manufacturing; Basic Organic Chemical Manufacturing; Plastic Materals
and Resin Manufacturing; Adhesive Manufacturing; Chemical Product and Preparation
Manufacturing; Paper Manufacturing; Paint and Coating Manufacturing; Plastic Products
Manufacturing; Synthetic Rubber Manufacturing; Wood Product Manufacturing;
Construction; Agriculture, Forestry, Fishing, and Hunting 30
A.5 Processing - Reactant - Functional Fluid in: Oil and Gas Drilling, Extraction, and Support
Activities 31
A.6 Processing - Reactant - Processing Aids, Specific to Petroleum Production in Basic
Chemical Manufacturing 31
A.7 Processing - Reactant - Bleaching Agent in Wood Product Manufacturing 31
A.8 Processing - Reactant - Agricultural Chemicals in Agriculture, Forestry, Fishing, and
Hunting 31
A.9 Processing - Incorporation into an Article - Finishing Agents in Textiles, Apparel, and
Leather Manufacturing 32
A. 10 Processing - Incorporation into an Article - Paint Additives and Coating Additives Not
Described by Other Categories in Transportation Equipment Manufacturing (Including
Aerospace) 32
A. 11 Processing - Incorporation into an Article - Additive in Rubber Product Manufacturing 33
A. 12 Processing - Incorporation into an Article - Adhesives and Sealant Chemicals in Wood
Product Manufacturing; Plastic Material and Resin Manufacturing (Including Structural and
Page 2 of 69
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Fireworthy Aerospace Interiors); Construction (Including Roofing Materials); Paer
Manufacturing 33
A. 13 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Petrochemical
Manufacturing, Petroleum, Lubricating Oil and Grease Manufacturing; Fuel and Fuel
Additives; Lubricant and Lubricant Additives; Basic Organic Chemical Manufacturig; and
Petroleum and Coal Products Manufacturing 35
A. 14 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Asphalt,
Paving, Roofing, and Coating Materials Manufacturing 35
A. 15 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Solvents
(Which Become Part of a Product Formulation or Mixture) in Paint and Coating
Manufacturing 35
A. 16 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Processing
Aids, Specific to Petroleum Production in: Oil and Gas Drilling, Extraction, and Support
Activities; Chemical Product and Preparation Manufacturing; and Basic Inorgaic Chemical
Manufacturing 35
A. 17 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Paint
Additives and Coating Additives Not Described by Other Categories in: Paint and Coating
Manufacturing; Plastic Material and Resin Manufacturing 36
A. 18 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Intermediate
in: Basic Chemical Manufacturing; Chemical Product and Preparation Manufacturing; Plastic
Material and Resin Manufacturing; Oil and Gas Drilling, Extraction, and Spport Activities;
Wholesale and Retail Trade 36
A. 19 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Solid
Separation Agents in Miscellaneous Manufacturing 36
A.20 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Agricultural
Chemicals (nonpesticidal) in: Agriculture, Forestry, Fishing, and Hunting; Pesticide,
Fertilizer, and Agricultural Chemical Manufacturing 36
A.21 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Surface
Active Agents in Plastic Material and Resin Manufacturing 37
A.22 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Ion Exchange
Agents in Adhesive Manufacturing and Paint and Coating Manufacturing 37
A.23 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Lubricant and
Lubricant Additive in Adhesive Manufacturing 37
A.24 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Plating
Agents and Surface Treating Agents in Chemical Product and Preparation Manufacturing 37
A.25 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Soap,
Cleaning Compound, and Toilet Preparation Manufacturing 38
A.26 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Laboratory
Chemicals 38
A.27 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Adhesive and
Sealant Chemical in Adhesive Manufacturing 38
A.28 Processing - Incorporation into a Formulation, Mixture, or Reaction Product - Bleaching
Agents in Textile, Apparel, and Leather Manufacturing 38
A.29 Processing - Repackaging - Sales to Distributors for Laboratory Chemicals 38
A.30 Processing - Recycling 39
A.31 Distribution in Commerce 39
A.32 Industrial Use - Non-Incorporative Activities - Process Aid in: Oil and Gas Drilling,
Extraction, and Support Activities; Process Aid Specific to Petroleum Production, Hydraulic
Fracturing 39
Page 3 of 69
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A.33 Industrial Use - Non-Incorporative Activities - Used in: Construction 40
A.34 Industrial Use - Non-Incorporative Activities - Oxidizing/ Reducing Agent; Processing
Aids, Not Otherwise Listed 41
A.35 Industrial Use - Industrial Products - Paints and Coatings; Adhesives and Sealants;
Lubricants 41
A.36 Industrial Use - Aerospace Use in: Paints and Coatings; Adhesives and Sealants; Lubricants;
and Foam Insulation 42
A.37 Commercial Use - Chemical Substances in Furnishings Treatment/Care Products - Floor
Coverings; Foam Seating and Bedding Products; Furniture and Furnishings Including Stone,
Plaster, Cement, Glass and Ceramic Articles; Metal Articles; or Rubber Articles; leaning and
Furniture Care Products; Leather Conditioner; Leather Tanning, Dye, Finishing Impregnation
and Care Products; Textile (Fabric) Dyes; Textile Finishing and Impregnating/Surface
Treatment Products 42
A.38 Commercial Use - Chemical Substances in Treatment Products - Water Treatment Products . 43
A.39 Commercial Use - Chemical Substances in Treatment/Care Products - Laundry and
Dishwashing Products 43
A.40 Commercial Use - Chemical Substances in Construction, Paint, Electrical, and Metal
Products - Adhesives and Sealants; Paint and Coatings 43
A.41 Commercial Use - Chemical Substances in Construction, Paint, Electrical, and Metal
Products - Construction and Building Materials Covering Large Surface Areas, Including
Wood Articles; Construction and Building Materials Covering Large Surface Areas,
Including Paper Articles; Metal Articles; Stone, Plaster, Cement, Glass and Ceramic Articles. 44
A.42 Commercial Use - Chemical Substances in Electrical Products - Machinery, Mechanical
Appliances, Electrical/Electronic Articles; Other Machinery, Mechanical Appliances,
Electronic/Electronic articles 44
A.43 Commercial Use - Chemical Substances in Metal Products - Construction and Building
Materials Covering Large Surface Areas, Including Metal Articles 45
A.44 Commercial Use - Chemical Substances in Automotive and Fuel Products - Automotive
Articles and Automotive Care Products; Lubricants and Greases; Fuels and Related Products. 45
A.45 Commercial Use - Chemical Substances in Agriculture Use Products - Lawn and Garden
Products 46
A.46 Commercial Use - Chemical Substances in Outdoor Use Products - Explosive Material 46
A.47 Commercial Use - Chemical Substances in Packaging, Paper, Plastic, Hobby Products -
Paper Products; Plastic and Rubber Products; Toys, Playground, and Sporting Equipment 46
A.48 Commercial Use - Chemical Substances in Packaging, Paper, Plastic, Hobby Products -
Arts, Crafts, and Hobby Materials 47
A.49 Commercial Use - Chemical Substances in Packaging, Paper, Plastic, Hobby Products - Ink,
Toner, and Colorant Products; Photographic Supplies 47
A.50 Commercial Use - Chemical Substances in Products Not Described by Other Codes -
Laboratory Chemicals 48
A.51 Consumer Use - Chemical Substances in Furnishings Treatment/Care Products - Floor
Coverings (Including Stone, Plaster, Cement, Glass and Ceramic Articles); Foam Seating and
Bedding Products; Cleaning and Furniture Care Products; Furniture and Furnishings Metal
Articles; or Rubber Articles 48
A.52 Consumer Use - Chemical Substances in Furnishings Treatment/Care Products - Fabric,
Textile, and Leather Products (Clothing) 49
A.53 Consumer Use - Chemical Substances in Treatment Products - Water Treatment Products 49
A.54 Consumer Use - Chemical Substances in Treatment/Care Products - Laundry and
Dishwashing Products 49
Page 4 of 69
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A.55 Consumer Use - Chemical Substances in Construction, Paint, Electrical, and Metal Products
- Adhesives and Sealants; Paint and Coatings 50
A,56 Consumer Use - Chemical Substances in Construction, Paint, Electrical, and Metal Products
- Construction and Building Materials Covering Large Surface Areas, Including Wood
Articles; Construction and Building Materials Covering Large Surface Areas, Including
Paper Articles; Metal Articles; Stone, Plaster, Cement, Glass and Ceramic Articles 50
A.57 Consumer Use - Chemical Substances in Electrical Products - Machinery, Mechanical
Appliances, Electrical/Electronic Articles; Other Machinery, Mechanical Appliances,
Electronic/Electronic articles 50
A.58 Consumer Use - Chemical Substances in Automotive and Fuel Products - Automotive
Articles and Automotive Care Products; Lubricants and Greases; Fuels and Related Products. 51
A.59 Consumer Use - Chemical Substances in Agriculture Use Products - Lawn and Garden
Products 51
A.60 Consumer Use - Chemical Substances in Packaging, Paper, Plastic, Hobby Products - Paper
Products; Plastic and Rubber Products; Toys, Playground, and Sporting Equipment 51
A.61 Consumer Use - Chemical Substances in Packaging, Paper, Plastic, Hobby Products - Arts,
Crafts, and Hobby Materials 52
A.62 Consumer Use - Chemical Substances in Packaging, Paper, Plastic, Hobby Products - Ink,
Toner, and Colorant Products; Photographic Supplies 52
A.63 Disposal - Disposal 52
Appendix B REGULATORY HISTORY 54
B.l Federal Laws and Regulations 54
B,2 State Laws and Regulations 65
B.3 International Laws and Regulations 66
LIST OF TABLES
Table 2-1. Conditions of Use Included in the Risk Evaluation for Formaldehyde 8
Table 2-2. Additions and Name Changes to Categories and Subcategories of Conditions of Use Based on
Updated Reporting in the 2020 CDR 14
Table 2-3. Additions and Name Changes to Categories and Subcategories of Conditions of Use Based on
Public Comments Received 16
Table 2-4. Subcategories Removed from the Risk Evaluation 17
LIST OF APPENNDIX TABLES
Table_Apx B-l. Federal Laws and Regulations 54
Table_Apx B-2. State Laws and Regulations 65
Table Apx B-3. Regulatory Actions by Other Governments and Tribes 66
Page 5 of 69
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1 INTRODUCTION
This document provides an overview of the conditions of use (COUs) considered for the formaldehyde
risk evaluation, pursuant to the TSCA section 3(4) definition of "conditions of use" and TSCA section
3(2) definition of "chemical substance." EPA did not directly assess risk from any formaldehyde
exposures occurring from non-TSCA uses (e.g., exposures from biogenic production of formaldehyde or
uses excluded from the TSCA section 3(2) definition of chemical substance, such as pesticides used for
embalming and taxidermy as well as any food, food additive, drug, cosmetic, or device). However, EPA
did consider potential exposures from non-TSCA uses, as appropriate, to help inform the Agency's risk
determination for formaldehyde under the TSCA conditions of use. This document also presents an
explanation of the scope of certain conditions of use of formaldehyde and explains EPA's rationale for
any changes to the scope of the risk evaluation after publication of the Final Scope for the Risk
Evaluation for Formaldehyde; 50-00-0 (U.S. EPA. 2020c).
Page 6 of 69
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2 RISK EVALUATION SCOPE
The formaldehyde risk evaluation comprises a series of assessments spread across may documents. A
basic diagram showing the layout and relationships of these assessments is provided in Figure 2-1. In
some cases, individual assessments were completed jointly under TSCA and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
Systematic
Review
Conditions
of Use
Environmental
Release
Assessment
Chemistry,
Fate, and
Transport
Assessment
Environmental
Exposure
Assessment
Environmental
Hazard
Assessment
Human Health
Risk Assessment
Environmental
RiskAssessment
Risk
Assessment
Summary
Risk
Determination
Human Health
Hazard
Assessment
legend
Q] TSCAAssessment
| TSCA/FIFRAShared Assessment
3) IRIS Assessment
f~~j Group of Assessments
Figure 2-1. Risk Evaluation Document Summary Map
2.1 Conditions of Use Included in the Risk Evaluation
The Final Scope for the Risk Evaluation for Formaldehyde; CASRN 50-00-0 ( J.S. EPA. 2020c) (2020
Final Scope) identified and described the categories and subcategories of COUs that EPA planned to
consider in the formaldehyde risk evaluation. TSCA § 3(4) defines "conditions of use" (COUs) as "the
circumstances, as determined by [EPA], under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of."
Table 2-1 presents all COUs for formaldehyde.
In the Draft Risk Evaluation for Formaldehyde, EPA edited the formaldehyde COUs listed in the 2020
Final Scope. Those edits reflected EPA's improved understanding of formaldehyde's COUs based on
further outreach, public comments received, and updated processing, industrial, consumer, and
commercial product category names for reporting under the Chemical Data Reporting (CDR) for 2020.
Those edits included: (1) updated additions based on new reporting in CDR for 2020; (2) updated
product category name changes based on new codes used in CDR for 2020; and (3) changes based on
IRIS
Assessment
Page 7 of 69
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EPA's further understanding of non-TSCA uses for formaldehyde that were initially included as TSCA
COUs for formaldehyde in the 2020 Final Scope. EPA further examined some COU subcategories
included in the 2020 Final Scope and determined that the subcategories were not formaldehyde COUs,
either because EPA determined that the uses are excluded from the TSCA section (2) definition of
"chemical substance" or that the uses are not actually circumstances under which formaldehyde is
intended, known, or reasonably foreseen to manufactured, processed, distributed in commerce, used, or
disposed of. These subcategories are further discussed in Section 2.2 and were removed from the draft
risk evaluation. In addition, certain exposure pathways that are administered by other EPA statutes, such
as TSCA Title VI, were included in the final risk evaluation and are further discussed in Section 2.4.
In this final risk evaluation, as described in Section 2.1.2, EPA added one COU in the final risk
evaluation based on public comment received on the Draft Risk Evaluation for Formaldehyde. EPA has
also further clarified certain COU uses and activities in Section 2.2 determined not to be chemical
substances based on public comment and new information received between the Final Scope for the Risk
Evaluation for Formaldehyde; CASRN 50-00-0 and this final risk evaluation.
Table 2-1 presents the COUs that were included and evaluated in this risk evaluation for formaldehyde.
Appendix A provides a description of the COUs included in this risk evaluation.
Table 2-1. Conditions of Use Inclut
ed in the Risk Evaluation for Formaldehyde
Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
Manufacturing
Domestic
manufacturing
Domestic manufacturing
U.S. EPA (2019a)
Manufacturing
Importing
Importing
U.S. EPA (2019a)
Processing
Reactant
Adhesives and sealant chemicals in: plastic
and resin manufacturing; wood product
manufacturing; paint and coating
manufacturing; basic organic chemical
manufacturing
U.S. EPA (2019a)
Processing
Reactant
Intermediate in: pesticide, fertilizer, and
other agricultural chemical manufacturing;
petrochemical manufacturing; soap,
cleaning compound, and toilet preparation
manufacturing; basic organic chemical
manufacturing; plastic materials and resin
manufacturing; adhesive manufacturing;
chemical product and preparation
manufacturing; paper manufacturing; paint
and coating manufacturing; plastic products
manufacturing; synthetic rubber
manufacturing; wood product
manufacturing; construction; agriculture,
forestry, fishing, and hunting
U.S. EPA (2019a)
Processing
Reactant
Functional fluid in: oil and gas drilling,
extraction, and support activities
U.S. EPA (2019a)
Page 8 of 69
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Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
Processing
Reactant
Processing aids, specific to petroleum
production in basic chemical manufacturing
U.S. EPA (2019a)
Processing
Reactant
Bleaching agent in wood product
manufacturing
U.S. EPA (2019a)
Processing
Reactant
Agricultural chemicals in agriculture,
forestry, fishing, and hunting
U.S. EPA (2019a)
Processing
Incorporation into an
article
Finishing agents in textiles, apparel, and
leather manufacturing
U.S. EPA (2019a);
USTMA (EPA-HO-OPPT-
2018-0438-0054)
Processing
Incorporation into an
article
Paint additives and coating additives not
described by other categories in
transportation equipment manufacturing
(including aerospace)
U.S. EPA (2019a); AIA
(EPA-HO-OPPT-2018-
0438-0006)
Processing
Incorporation into an
article
Additive in rubber product manufacturing
USTMA (EPA-HO-OPPT-
2018-0438-0026); USTMA
(EPA-HO-OPPT-2018-
0438-0054)
Processing
Incorporation into an
article
Adhesives and sealant chemicals in wood
product manufacturing; plastic material and
resin manufacturing (including structural
and fireworthy aerospace interiors);
construction (including roofing materials);
paper manufacturing
U.S. EPA (2019a); AIA
(EPA-HO-OPPT-2018-
0438-0006); ARMA (EPA-
HO-OPPT2018-043 8-
0005); ARMA (EPA-HO-
OPPT-2018-0438- 0051);
USTMA (EPA-HOOPPT-
2018-0438-0054)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Petrochemical manufacturing, petroleum,
lubricating oil and grease manufacturing;
fuel and fuel additives; lubricant and
lubricant additives; basic organic chemical
manufacturing; and petroleum and coal
products manufacturing
U.S. EPA (2019a); AIA
(EPA-HO-OPPT-2018-
0438-0006); Everlube
(EPA-HO-OPPT2018-
0438-0024)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Asphalt, paving, roofing, and coating
materials manufacturing
U.S. EPA (2019a); ARMA
(EPA-HO-OPPT-2018-
0438-0005)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Solvents (which become part of a product
formulation or mixture) in paint and
coating manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Processing aids, specific to petroleum
production in: oil and gas drilling,
extraction, and support activities; chemical
product and preparation manufacturing; and
basic inorganic chemical manufacturing
U.S. EPA (2019a); AIA
(EPAHO-OPPT-2018-
0438-0006); EDF (EPA-
HO-OPPT-2018- 0438-
0017)
Page 9 of 69
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Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Paint additives and coating additives not
described by other categories in: paint and
coating manufacturing; plastic material and
resin manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Intermediate in: basic chemical
manufacturing; chemical product and
preparation manufacturing; plastic material
and resin manufacturing; oil and gas
drilling, extraction, and support activities;
wholesale and retail trade
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Solid separation agents in miscellaneous
manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Agricultural chemicals (nonpesticidal) in:
Agriculture, forestry, fishing, and hunting;
pesticide, fertilizer, and agricultural
chemical manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Surface active agents in plastic material and
resin manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Ion exchange agents in adhesive
manufacturing and paint and coating
manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Lubricant and lubricant additive in
adhesive manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Plating agents and surface treating agents in
chemical product and preparation
manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Soap, cleaning compound, and toilet
preparation manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Laboratory chemicals
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Adhesive and sealant chemical in adhesive
manufacturing
U.S. EPA (2019a)
Processing
Incorporation into a
formulation, mixture,
or reaction product
Bleaching agents in textile, apparel, and
leather manufacturing
U.S. EPA (2019a)
Processing
Repackaging
Sales to distributors for laboratory
chemicals
U.S. EPA (2019a)
Page 10 of 69
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Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
Processing
Recycling
Recycling
U.S. EPA (2019a)
Distribution in
commerce
Distribution in
commerce
Distribution in commerce
Industrial Use
Non-incorporative
activities
Process aid in: oil and gas drilling,
extraction, and support activities; process
aid specific to petroleum production,
hydraulic fracturing
U.S. EPA (2019a); EDF
(EPAHO-OPPT-2018-
0438-0017)
Industrial Use
Non-incorporative
activities
Used in: construction
U.S. EPA (2019a)
Industrial Use
Non-incorporative
activities
Oxidizing/reducing agent; processing aids,
not otherwise listed
IPC (EPA-HO-OPPT-
2018- 0438-0025): IPC
(EPA-HO-OPPT043 8-
0050); SAI (EPA-HO-
OPPT-0438-0053)
Industrial Use
Chemical substances
in industrial products
Paints and coatings; adhesives and sealants;
lubricants
AFS (EPA-HO-OPPT-
2023-0613-0234); AIA
(EPA-HO-OPPT-2018-
0438-0006):
Industrial Use
Chemical substances
in industrial products
Aerospace use in: paints and coating;
adhesives and sealants; lubricants; and
foam insulation
AIA (EPA-HO-OPPT-
2018- 0438-0006); AIA
(EPA-HO-OPPT-2023-
0613-0199)
Commercial
Uses
Chemical substances
in furnishing
treatment/care
products
Floor coverings; foam seating and bedding
products; furniture & furnishings including
stone, plaster, cement, glass and ceramic
articles; metal articles; or rubber articles;
cleaning and furniture care products;
leather conditioner; leather tanning, dye,
finishing impregnation and care products;
textile (fabric) dyes; textile finishing and
impregnating/ surface treatment products.
U.S. EPA (2020a): U.S.
EPA (2019a);
Commercial
Uses
Chemical substances
in treatment products
Water treatment products
U.S. EPA (2019a)
Commercial
Uses
Chemical substances
in treatment/care
products
Laundry and dishwashing products
U.S. EPA (2019a)
Commercial
Uses
Chemical substances
in construction, paint,
electrical, and metal
products
Adhesives and sealants; paint and coatings
U.S. EPA (2019a)
Commercial
Uses
Chemical substances
in furnishing
treatment/care
products
Construction and building materials
covering large surface areas, including
wood articles; construction and building
materials covering large surface areas,
including paper articles; metal articles;
stone, plaster, cement, glass and ceramic
articles
U.S. EPA (2019a); U.S.
EPA (2020a)
Page 11 of 69
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Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
Commercial
Chemical substances
Machinery, mechanical appliances,
U.S. EPA (2019a)
Uses
in electrical products
electrical/electronic articles; other
machinery, mechanical appliances,
electronic/electronic articles
Commercial
Chemical substances
Construction and building materials
U.S. EPA (2019a);
Uses
in metal products
covering large surface areas, including
metal articles
Commercial
Chemical substances
Automotive articles and automotive care
U.S. EPA (2019a):
uses
in automotive and
products; lubricants and greases; fuels and
USTMA (EPA-HO-OPPT-
fuel products
related products
2018-0438- 0026);
Everlube (EPA-HO-OPPT-
2018-0438-0024)
Commercial
Chemical substances
Lawn and garden products
U.S. EPA (2019a)
uses
in agriculture use
products
Commercial
Chemical substances
Explosive materials
U.S. EPA (2019a)
Uses
in outdoor use
products
Commercial
Chemical substances
Paper products; plastic and rubber
U.S. EPA (2019a); ACA
Uses
in packaging, paper,
plastic, hobby
products
products; toys, playground, and sporting
equipment
(EPA-HO-OPPT-2018-
0438- 0023); ACC (EPA-
HO-OPPT-2018-043 8-
0018)
Commercial
Chemical substances
Arts, crafts, and hobby materials
U.S. EPA (2019a)
uses
in packaging, paper,
plastic, hobby
products
Commercial
Chemical substances
Ink, toner, and colorant products;
U.S. EPA (2019a);
Uses
in packaging, paper,
plastic, hobby
products
photographic supplies
Commercial
Chemical substances
Laboratory Chemicals
U.S. EPA (2019a)
Uses
in products not
described by other
codes
Consumer Uses
Chemical substances
in furnishing
treatment/care
products
Floor coverings; foam seating and bedding
products; cleaning and furniture care
products; furniture & furnishings including
stone, plaster, cement, glass and ceramic
articles; metal articles; or rubber articles
U.S. EPA (2019a); U.S.
EPA (2020a)
Consumer Uses
Chemical substances
Fabric, textile, and leather products not
U.S. EPA (2019a); U.S.
in furnishing
treatment/care
covered elsewhere (clothing)
EPA (2020a)
products
Consumer Uses
Chemical substances
in treatment products
Water treatment products
U.S. EPA (2019a)
Page 12 of 69
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Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
Consumer Uses
Chemical substances
in treatment/care
products
Laundry and dishwashing products
U.S. EPA (2019a)
Consumer Uses
Chemical substances
in construction, paint,
electrical, and metal
products
Adhesives and Sealants; paint and coatings
U.S. EPA (2019a)
Consumer Uses
Chemical substances
in construction, paint,
electrical, and metal
products
Construction and building materials
covering large surface areas, including
wood articles; construction and building
materials covering large surface areas,
including paper articles; metal articles;
stone, plaster, cement, glass and ceramic
articles
U.S. EPA (2019a); U.S.
EPA (2020a)
Consumer Uses
Chemical substances
in electrical products
Machinery, mechanical appliances,
electrical/electronic articles; other
machinery, mechanical appliances,
electronic/electronic articles
U.S. EPA (2019a)
Consumer Uses
Chemical substances
in automotive and
fuel products
Automotive articles and automotive care
products; lubricants and greases; fuels and
related products
U.S. EPA (2019a):
USTMA (EPA-HO-OPPT-
2018-0438- 0026);
Everlube (EPA-HO-OPPT-
2018-0438-0024)
Consumer Uses
Chemical substances
in agriculture use
products
Lawn and garden products
U.S. EPA (2019a)
Consumer Uses
Chemical substances
in packaging, paper,
plastic, hobby
products
Paper products; plastic and rubber
products; toys, playground, and sporting
equipment
U.S. EPA (2019a); ACA
(EPA-HO-OPPT-2018-
0438- 0023); ACC (EPA-
HO-OPPT-2018-043 8-
0018)
Consumer Uses
Chemical substances
in hobby products
Arts, crafts, and hobby materials
U.S. EPA (2019a)
Consumer Uses
Chemical substances
in packaging, paper,
and plastic
Ink, toner, and colorant products;
Photographic supplies
U.S. EPA (2019a)
Disposal
Disposal
Disposal
U.S. EPA (2019a)
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Life Cycle
Stage"
Category6
Subcategoryc
Reference(s)
11 Life Cycle Stage Use Definitions (40 CFR § 711.3)
- "Industrial use" means use at a site at which one or more chemicals or mixtures are manufactured (including
imported) or processed.
- "Commercial use" means the use of a chemical or a mixture containing a chemical (including as part of an article)
in a commercial enterprise providing saleable goods or services.
- "Consumer use" means the use of a chemical or a mixture containing a chemical (including as part of an article,
such as furniture or clothing) when sold to or made available to consumers for their use.
- Although EPA has identified both industrial and commercial uses here for purposes of distinguishing scenarios in
this document, the Agency interprets the authority over "any manner or method of commercial use" under TSCA
Section 6(a)(5) to reach both.
h These categories of conditions of use appear in the Life Cycle Diagram, reflect CDR codes, and broadly represent
conditions of use of formaldehyde in industrial and/or commercial settings and for consumer uses.
c These subcategories reflect more specific conditions of use of formaldehyde.
2.1.1 Additions and Name Changes to Conditions of Use Based on Updated 2020 CDR
Reported Data
After the 2020 Final Scope, EPA received updated submissions under the 2020 CDR reported data. In
addition to new submissions received under the 2020 CDR, the reporting name codes changed for the
2020 CDR reporting cycle. Therefore, EPA amended the description of certain formaldehyde COUs
based on those new submissions and new reporting name codes. Table 2-2 summarizes the changes to
the COUs based on the new reporting codes in the 2020 CDR. Those changes are included in Table 2-1
Table 2-2. Additions and Name Changes to Categories and Subcategories of Conditions of Use
Based on Updat
ed Reporting in the 2020 CDR
Life Cycle
Stage and
Category
Original Subcategory in the 2020
Scope Document
Occurred
Change
Revised Subcategory in the 2024
Risk Evaluation
Processing -
Reactant
Adhesives and sealant chemicals in:
plastic and resin manufacturing;
wood product manufacturing; all
other basic organic chemical
manufacturing
Added - 'paint
and coating
manufacturing"
Adhesives and sealant chemicals in:
plastic and resin manufacturing;
wood product manufacturing; paint
and coating manufacturing; basic
organic chemical manufacturing
Processing -
Reactant
Intermediate in: pesticide, fertilizer,
and other agricultural chemical
manufacturing; petrochemical
manufacturing; soap, cleaning
compound, and toilet preparation
manufacturing; all other basic organic
chemical manufacturing; plastic
materials and resin manufacturing;
adhesive manufacturing; all other
chemical product and preparation
manufacturing; paper manufacturing;
plastic products manufacturing; wood
product manufacturing; construction;
agriculture, forestry, fishing, and
hunting
Added - 'paint
and coating
manufacturing"
Added -
'synthetic rubber
manufacturing"
Intermediate in: pesticide, fertilizer,
and other agricultural chemical
manufacturing; petrochemical
manufacturing; soap, cleaning
compound, and toilet preparation
manufacturing; basic organic
chemical manufacturing; plastic
materials and resin manufacturing;
adhesive manufacturing; chemical
product and preparation
manufacturing; paper
manufacturing; paint and coating
manufacturing; plastic products
manufacturing; synthetic rubber
manufacturing; wood product
manufacturing; construction;
Page 14 of 69
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Life Cycle
Stage and
Category
Original Subcategory in the 2020
Scope Document
Occurred
Change
Revised Subcategory in the 2024
Risk Evaluation
agriculture, forestry, fishing, and
hunting
Processing -
Incorporation
into a
formulation,
mixture, or
reaction product
Petrochemical manufacturing,
petroleum, lubricating oil and grease
manufacturing; fuel and fuel
additives; lubricant and lubricant
additives; and all other basic organic
chemical manufacturing
Added -
'petroleum and
coal products
manufacturing"
Petrochemical manufacturing,
petroleum, lubricating oil and grease
manufacturing; fuel and fuel
additives; lubricant and lubricant
additives; basic organic chemical
manufacturing; and petroleum and
coal products manufacturing
Processing -
Incorporation
into a
formulation,
mixture, or
reaction product
Processing aids, specific to petroleum
production in: oil and gas drilling,
extraction, and support activities; and
all other basic inorganic chemical
manufacturing
Added -
'chemical
product and
preparation
manufacturing"
Processing aids, specific to
petroleum production in: oil and gas
drilling, extraction, and support
activities; chemical product and
preparation manufacturing; and
basic inorganic chemical
manufacturing
Processing -
Incorporation
into a
formulation,
mixture, or
reaction product
Functional fluids (closed system) in
soap, cleaning compound, and toilet
preparation manufacturing
Name change
based on new
industry code
Soap, cleaning compound, and toilet
preparation manufacturing
Commercial Use
- chemical
substances in
furnishing
treatment/care
products
Floor coverings; foam seating and
bedding products; furniture and
furnishings not covered elsewhere;
cleaning and furniture care products;
fabric, textile, and leather products
not covered elsewhere
Name change
based on new
industry code
Floor coverings; foam seating and
bedding products; furniture &
furnishings including stone, plaster,
cement, glass and ceramic articles;
metal articles; or rubber articles;
cleaning and furniture care products;
leather conditioner; leather tanning,
dye, finishing impregnation and care
products; textile (fabric) dyes;
textile finishing and impregnating/
surface treatment products.
Commercial Use
- chemical
substances in
furnishing
treatment/care
products
Building/construction materials -
wood and engineered wood products;
building/ construction materials not
covered elsewhere
Name change
based on new
industry code
Construction and building materials
covering large surface areas,
including wood articles;
construction and building materials
covering large surface areas,
including paper articles; metal
articles; stone, plaster, cement, glass
and ceramic articles
Commercial Use
- chemical
substances in
electrical
products
Electrical and electronic products
Name change
based on new
industry code
Machinery, mechanical appliances,
electrical/electronic articles; other
machinery, mechanical appliances,
electronic/electronic articles
Page 15 of 69
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Life Cycle
Stage and
Category
Original Subcategory in the 2020
Scope Document
Occurred
Change
Revised Subcategory in the 2024
Risk Evaluation
Commercial Use
- chemical
substances in
metal products
Metal products not covered elsewhere
Name change
based on new
industry code
Construction and building materials
covering large surface areas,
including metal articles
Consumer Use -
chemical
substances in
furnishing
treatment/care
products
Floor coverings; foam seating and
bedding products; cleaning and
furniture care products; furniture and
furnishings not covered elsewhere
Name change
based on new
industry code
Floor coverings; foam seating and
bedding products; cleaning and
furniture care products; furniture &
furnishings including stone, plaster,
cement, glass and ceramic articles;
metal articles; or rubber articles
Consumer Use -
chemical
substances in
furnishing
treatment/care
products
Building/construction materials -
wood and engineered wood products;
building/ construction materials not
covered elsewhere
Name change
based on new
industry code
Construction and building materials
covering large surface areas,
including wood articles;
construction and building materials
covering large surface areas,
including paper articles; metal
articles; stone, plaster, cement, glass
and ceramic articles
Consumer Use -
chemical
substances in
electrical
products
Electrical and electronic products
Name change
based on new
industry code
Machinery, mechanical appliances,
electrical/electronic articles; other
machinery, mechanical appliances,
electronic/electronic articles
2.1.2 Additions and Name Changes to Conditions of Use Based on Public Comments
Received on the Draft Risk Evaluation
After the Draft Risk Evaluation for Formaldehyde was published in March 2024, EPA received public
comments from certain industry and government agencies that supported an addition to the list of COU
subcategories under evaluation. Therefore, EPA amended the COU Table to include an additional COU
subcategory based on those comments. Table 2-3 summarizes the changes to the COUs based on
submitted public comments. Those changes are included in Table 2-1.
Table 2-3. Additions and Name Changes to Categories and Subcategories of Conditions of Use
Based on Public Comments Received
Life Cycle
Stage and
Category
Original Subcategory in the 2020
Scope Document
Occurred Change
Revised Subcategory in the 2024
Risk Evaluation
Industrial use -
chemical
substances in
industrial
products
N/A
Added new COU
based on public
comments for
aerospace use
Aerospace use in: paints and
coating; adhesives and sealants;
lubricants; and foam insulation
This COU, Aerospace use in: paints and coating; adhesives and sealants; lubricants; and foam insulation,
was added to the Formaldehyde Risk Evaluation based on detailed comments provided by the Aerospace
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Industries Association (AIA) (EPA-HQ-OPPT-2023-0613-0199). This commentor provided evidence
that certain uses of formaldehyde in aerospace products merited a separate, dedicated COU subcategory
based on these specialty uses ranging from anti-friction coating applications on airplanes to foam
sealants for rockets. This COU was evaluated for the final risk evaluation.
2.2 Activities Determined Not to Be Conditions of Use
Section 2.2.2 of the 2020 Final Scope explained that EPA determined that several uses of formaldehyde
were outside the scope of TSCA. When developing the draft risk evaluation, EPA concluded that some
subcategories of the conditions of use listed in the final scope are either excluded from the TSCA § 3(2)
definition of "chemical substance" or not actually circumstances under which formaldehyde is intended,
known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or
disposed of. Therefore, EPA removed those subcategories from the risk evaluation. Table 2-4
summarizes the changes to the COU subcategory descriptions between publication of the 2020 Final
Scope and publication of the 2024 draft risk evaluation. No further changes were made in this regard
between the draft and final risk evaluation
Table 2-4. Subcategories Removed from the Risk Evaluation
Life Cycle
Stage and Category
Original Subcategory in the 2020
Scope Document
Occurred Change
Revised Subcategory in
the 2024 Risk Evaluation
Processing;
Incorporation into a
formulation, mixture,
or reaction product
Other: preservative in all other
chemical product and preparation
manufacturing
Removed
N/A
Industrial Use; non-
incorporative
activities
Used in: construction and
agriculture, forestry, fishing, and
hunting
Removed "and
agriculture, forestry,
fishing, and hunting"
Used in: construction
Commercial Use -
chemical substances
in treatment/care
products
Laundry and dishwashing products;
personal care products (covered by
TSCA)
Removed "personal care
products (covered by
TSCA)"
Laundry and dishwashing
products
Commercial Use -
chemical substances
in packaging, paper,
plastic, hobby
products
Food packaging; paper products;
plastic and rubber products; toys,
playground, and sporting
equipment
Removed "food
packaging"
Paper products; plastic and
rubber products; toys,
playground, and sporting
equipment
Commercial Use -
chemical substances
in products not
described by other
codes
Laboratory chemicals (e.g.,
specimen preservation, medical
samples, mortuary science)
Removed "(e.g.,
specimen preservation,
medical samples,
mortuary science)"
Laboratory chemicals
Consumer Use -
chemical substances
in treatment/care
products
Laundry and dishwashing products;
personal care products (covered by
TSCA)
Removed "personal care
products (covered by
TSCA)"
Laundry and dishwashing
products
These activities were removed from the scope of the risk evaluation because they did not meet the
definition of "chemical substance" and instead, aligned with the Federal Insecticide, Fungicide, and
Rodenticide Act or the Federal Food, Drug, and Cosmetic Act, or because they were determined not to
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be circumstances under which formaldehyde is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of. Each activity is listed below
under each respective jurisdiction for clarity.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
TSCA section 3(2)(B)(ii) excludes from the "chemical substance" definition "any pesticide (as defined
in [FIFRA]) when manufactured, processed, or distributed in commerce for use as a pesticide."
Activities determined to be pesticidal uses under FIFRA include:
• Processing - incorporation into a formulation, mixture, or reaction product - "other:
preservative in all other chemical product and preparation manufacturing" was removed after
EPA determined that this is a pesticidal use under FIFRA. These preservative products meet the
definition of "pesticide" under FIFRA (7 U.S.C. § 136(u)) and are therefore excluded from the
TSCA § 3(2) definition of "chemical substance" when manufactured, processed, or distributed in
commerce for these uses. (Related: see Commercial Use - laboratory chemicals - "specimen
preservation, medical samples, mortuary science" below).
• Commercial Use - laboratory chemicals - "specimen preservation, medical samples, mortuary
science " were removed as listed examples because these terms encompass pesticidal uses under
FIFRA. Specifically, EPA has identified the following types of products as pesticides that are
exempt from the requirements of FIFRA: embalming fluids; products used to preserve animal or
animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of
learning; and products used to preserve the integrity of milk, urine, blood, or other body fluids
for laboratory analysis (see 40 CFR 152.25(c); 53 FR 15952, 15977 (May 4, 1988)). These
products meet the definition of "pesticide" under FIFRA (7 U.S.C. § 136(u)) and are therefore
excluded from the TSCA § 3(2) definition of "chemical substance" when manufactured,
processed, or distributed in commerce for these uses. Other uses of formaldehyde as a laboratory
chemical remain within the scope of the TSCA risk evaluation, such as fixative use for slide
preparation. Formaldehyde can be used in commercial laboratories for microscope slide
preparation and is used to bind proteins in order to make cells or tissues more structurally solid
in the short term. For example, an animal cell may be mobile on a glass slide so a fixative that
contains formaldehyde could be applied to that slide so the cell is no longer mobile. EPA has
determined that these fixative purposes are in scope because this use is considered non-
pesticidal. Use for slide preparation could potentially have a short-term fixative (non-
preservation) purpose if there is not also an intent to preserve the tissue for later analysis.
Federal Food, Drug, and Cosmetic Act (FFDCA)
TSCA section 3(2)(B)(vi) excludes from the "chemical substance" definition "any food, food additive,
drug, cosmetic, or device (as such terms are defined in . . . the Federal Food, Drug, and Cosmetic Act . .
.) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug,
cosmetic, or device." Activities determined to be uses under FFDCA or not to be intended, known, or
reasonably foreseen beyond the scope of the FFDCA exclusion include:
• Industrial Use - non-incorporative activities - "agriculture, forestry, fishing, and hunting" was
removed after EPA determined that this is not a circumstance under which formaldehyde is
intended, known, or reasonably foreseen to be used. Based on additional information provided by
the submitter of the 2016 CDR submission identifying this subcategory, EPA believes that the
correct interpretation of the submission is of an incorporative activity involving the use of
formaldehyde in the manufacture of animal feeds for agriculture and aquaculture/hatchery usage
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(Bakelite EPA-HQ-QPPT-2018-043 8-0134). Use of formaldehyde in animal feed meets the
definition of a food, food additive, or drug under the FFDCA (21 U.S.C. § 321) and is therefore
excluded from the TSCA § 3(2) definition of "chemical substance" when manufactured,
processed, or distributed in commerce for that use. For example, FDA currently regulates the use
of formaldehyde as a food additive in the manufacture of certain animal feeds under 21 CFR §
573.460 and as an animal drug (Formalin) to control external parasites on hatchery fish and their
eggs under 21 CFR § 529.1004.
• Commercial and Consumer Uses - "'personal care products (covered by TSCA) " under the
"laundry and dishwashing products; personal care products (covered by TSCA) " was removed
because, upon further investigation, EPA did not identify any formaldehyde-containing personal
care products covered by TSCA. Many personal care products meet the definition of cosmetic,
drug, or device under the FFDCA (21 U.S.C. § 321) and are therefore excluded from the TSCA §
3(2) definition of "chemical substance" when manufactured, processed, or distributed in
commerce for those uses. As noted in the final scope document for formaldehyde, such products
subject to FDA's jurisdiction were excluded from the final scope, and could include eyelash
adhesives, hair treatments, moisturizers, mouthwashes, hand cleaning creams, shampoos,
conditioners, deodorants, certain nail treatments, perfumes and fragrances, shaving creams, and
certain body cleansers containing synthetic detergents.
• Commercial Use - "food packaging" under the "food packaging; paper products; plastic and
rubber products; toys, playground, and sporting equipment" was removed because EPA
determined that the "food packaging" meets the definition of food additive under the FFDCA (21
U.S.C. § 321(s)) and is therefore excluded from the TSCA definition of "chemical substance"
when manufactured, processed, or distributed in commerce for that use.
2.2.1 Industries Affected by Activities Determined Not to Be Conditions of Use
Section 2.2.2 of the 2020 Final Scope explained that EPA determined that several uses of formaldehyde
were outside the scope of TSCA or were not considered. Consistent with the draft risk evaluation, this
unit provides clarifications and details for certain uses outside the scope of TSCA based on public
request to explicitly state which uses will not be covered under the formaldehyde risk evaluation.
Aquaculture, Hatchery, and Animal Feeds
In the 2020 Final Scope, EPA explained TSCA Section 3(2) excludes from the definition of "chemical
substance" "any food, food additive, drug, cosmetic, or device (as such terms are defined in Section 201
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug, cosmetic, or device." EPA is clarifying
that the use of formaldehyde in animal feed or as an animal drug meets the definition of a "food, food
additive, [or] drug," respectively, under the FFDCA (21 U.S.C. § 321), and is therefore excluded from
the TSCA § 3(2) definition of "chemical substance" when manufactured, processed, or distributed in
commerce for that use. For example, FDA regulates the use of formaldehyde as a food additive in the
manufacture of certain animal feeds under 21 CFR § 573.460, and as an animal drug (formalin) to
control external parasites on hatchery fish and their eggs under 21 CFR § 529.1004.
Embalming and Taxidermy
In the 2020 Final Scope EPA explained TSCA Section 3(2) also excludes from the definition of
"chemical substance" "any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.]) when manufactured, processed, or distributed in commerce for use as a
pesticide." Products intended for use as a preservative for biological specimens in embalming and
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taxidermy are considered pesticides under FIFRA. EPA has identified the following types of products as
pesticides that are exempt from the requirements of FIFRA: embalming fluids; products used to preserve
animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of
learning; and products used to preserve the integrity of milk, urine, blood, or other body fluids for
laboratory analysis (see 40 CFR 152.25(c); 53 FR 15952, 15977, (May 4, 1988)). Because these
products meet the definition of "pesticide" under FIFRA (7 U.S.C. § 136(u)), such formaldehyde-
containing products are therefore excluded from the TSCA § 3(2) definition of "chemical substance"
when manufactured, processed, or distributed in commerce for these uses.
Because embalming and taxidermy products intended for preservation of biological specimens are
considered pesticides under FIFRA and because FIFRA has a specific exemption for pesticides used for
biological preservation under the circumstances described in 40 CFR 152.25(c), uses that fall within the
40 CFR 152.25(c) exemption from regulation under FIFRA are not covered by either the Office of
Pesticide Programs formaldehyde registration review under FIFRA or by OPPT in this TSCA risk
evaluation.
2.2.2 Biogenic Sources of Formaldehyde Not Considered as Conditions of Use
EPA does not consider biogenic formation of formaldehyde, such as emissions from trees, plants, and
soil microbes, to be conditions of use under TSCA section 3(4). The biogenic formation can
significantly contribute to total formaldehyde concentration in ambient air. For purposes of this TSCA
risk evaluation for formaldehyde, some of the data used in the ambient air exposure assessment includes
the biogenic formation and other sources of formaldehyde.
2.3 Secondary Formation of Formaldehyde and Certain Combustion
Sources
Formaldehyde can be emitted from many types of combustion. In indoor settings these can include
burning candles, tobacco smoke, fireplaces and household appliances. These sources can also include
tailpipe emissions (including cars, trucks and boats), emissions from outdoor fires (including wildfires,
prescribed fires and agricultural burning), and emissions from industrial sources. Some combustion
activities that produce formaldehyde could occur during the manufacture, processing, use or disposal of
another chemical substance(s) or mixture(s).
Significant concentrations of formaldehyde are also found in the environment due to secondary
formation of the chemical after degradation of other compounds, for example when a different chemical
undergoes chemical reactions in the air and forms formaldehyde.
Combustion sources and secondary formation of formaldehyde are so abundant and likely result in co-
occurring exposures. For purposes of this TSCA risk evaluation for formaldehyde, EPA considered
ambient (outdoor) and indoor air monitoring data that is expected to represent formaldehyde
concentrations attributable to a variety of sources, which may include secondary formation and/or
combustion, including, data related to short term and long-term exposures to people living or working
near facilities releasing formaldehyde (fenceline populations).
2.4 Additions to the Scope Pertaining to Exposure Pathways and Risks
Addressed by Other EPA-Administered Statutes
Section 2.6.3.1 of the 2020 Final Scope explained that EPA would not consider certain exposure
pathways and risks addressed by other EPA-administered statutes. As first announced on June 30, 2021,
and codified by regulation at 40 CFR 702.39(d)(9) in 2024, EPA is no longer excluding exposure
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pathways that are addressed under other EPA-administered statutes or regulatory programs from the
scope of TSCA risk evaluations. As explained in the preamble to the final rule, Procedures for Chemical
Risk Evaluation Under the Toxic Substances Control Act (89 FR 37028, May 3, 2024), EPA
reconsidered the text of the relevant statutory provisions, overarching statutory structure and context,
and legislative history, and no longer interprets the law to authorize exclusion of exposure pathways
from the scope of TSCA risk evaluations because other EPA offices have already or could in the future
regulate those chemicals. Accordingly, consistent with the draft risk evaluation, EPA has included in the
final formaldehyde risk evaluation the exposure pathways described below and in Section 2.6.3.1 of the
2020 Final Scope.
Composite Wood Products Under TSCA Title VI
EPA stated in the 2020 Final Scope that the Agency had determined that three types of composite wood
products (hardwood plywood, particleboard, and medium density fiberboard [including thin-medium
density fiberboard]), and laminated products currently regulated under the Formaldehyde Emission
Standards for Composite Wood Products final rule (40 CFR part 770, promulgated under TSCA Title
VI), would not be included in the scope of the risk evaluation. Since the 2020 Final Scope's publication,
EPA has now included exposure pathways that are addressed under other EPA-administered statutes or
regulatory programs in the scope of TSCA risk evaluations. Therefore, all composite wood products,
including those regulated under TSCA Title VI, are included in the formaldehyde risk evaluation.
EPA determined that excluding TSCA Title VI regulated composite wood products from the
formaldehyde risk evaluation would reduce the comprehensiveness of the risk evaluation and introduce
complexities and uncertainties due to the regulated vs. non-regulated materials that may be present in a
finished good in indoor environments.
Regulated composite wood products under TSCA Title VI include hardwood plywood, medium density
fiberboard, and particle board. These products and articles are included in the following COUs:
• Commercial use in floor coverings; foam seating and bedding products; furniture & furnishings
including stone, plaster, cement, glass and ceramic articles; metal articles; or rubber articles;
cleaning andfurniture care products; leather conditioner; leather tanning, dye, finishing,
impregnation and care products; textile (fabric) dyes; textile finishing and impregnating/surface
treatment products;
• Commercial use in construction and building materials covering large surface areas, including
wood articles; construction and building materials covering large surface areas, including paper
articles; metal articles; stone, plaster, cement, glass and ceramic articles;
• Consumer use in floor coverings; foam seating and bedding products; cleaning andfurniture
care products; furniture & furnishings including stone, plaster, cement, glass and ceramic
articles; metal articles; or rubber articles;
• Consumer use in construction and building materials covering large surface areas, including
wood articles; construction and building materials covering large surface areas, including paper
articles; metal articles; stone, plaster, cement, glass and ceramic articles.
Exposure Pathways from Ambient Air, Drinking Water, Onsite Releases to Land, Disposal and Soil
The formaldehyde risk evaluation includes exposure pathways from ambient air, drinking water, onsite
releases to land, disposal and soil that were described in Section 2.6.3.1 of the 2020 Final Scope
document. The conceptual model depicted in Figure 2-15 of the 2020 Final Scope document has been
updated in Figure 1-7 of the Human Health Risk Assessment for Formaldehyde to reflect the exposure
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pathways, exposure routes and hazards to human receptors from releases and wastes from industrial,
commercial, and consumer uses of formaldehyde that EPA considered in the risk evaluation.
2.5 Clarification Regarding Consideration of Formalin and
Paraformaldehyde in the Risk Evaluation
Formalin
Formaldehyde is a gas that is distributed in solution as formalin. Formalin is a formulation of
formaldehyde in aqueous solution and is composed of three components - formaldehyde, methanol, and
water. It occurs as a colorless liquid at room temperature. Therefore, formalin was assessed as a part of
the formaldehyde risk evaluation under the TSCA conditions of use as listed in Table 2-1. It should be
noted that certain uses of formalin, such as the use as an animal drug as defined in the FFDCA to control
external parasites on hatchery fish and their eggs, are excluded from the TSCA § 3(2) definition of
"chemical substance" and therefore not included in the risk evaluation.
Paraformaldehyde
Paraformaldehyde was not assessed since it is considered a different chemical substance, with a different
CAS number (30525-89-4), and not prioritized or included in the Final Scope of the Risk Evaluation for
Formaldehyde (HCHO); CASRN 50-0-0.
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3 REFERENCES
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Appendix A DESCRIPTION OF CONDITIONS OF USE
The following descriptions are intended to include examples of uses, so as not to exclude other activities
that may also be included in the COUs of the chemical substance. To better describe the COU, EPA
considered CDR submissions from the last two CDR cycles for formaldehyde (CASRN 50-00-0), public
comments submitted on the draft scope and draft risk evaluation, and stakeholder meetings. The COU
descriptions reflect what EPA identified as the best fit for each type of submission and information.
Examples of articles, products, or activities are included in the following descriptions to help describe
the COU but are not exhaustive. EPA uses the terms "articles" and "products" or product mixtures in the
following descriptions and is generally referring to articles and products as defined by 40 CFR 751.5.
There may be instances where the terms are used interchangeably by a company or commenters, or by
EPA in reference to a code from the CDR reports which are referenced, e.g. "plastic products
manufacturing," or "fabric, textile, and leather products." EPA will clarify as needed when these
references are included throughout the COU descriptions below.
A.l Manufacturing - Domestic Manufacturing
Domestic manufacturing means to manufacture or produce formaldehyde within the United States. For
purposes of the formaldehyde risk evaluation, this includes the extraction of formaldehyde from a
previously existing chemical substance or complex combination of chemical substances and loading and
repackaging (but not transport) associated with the manufacturing, production of formaldehyde. This
condition of use includes the two commonly used manufacturing processes described below.
Currently, most formaldehyde is manufactured using one of two methods using methanol and air as
feedstocks: a silver-catalyst-based process and a metal-oxide-catalyst-based process (Krali. 2015;
Gerberich and Seaman. 2013; NICNAS. 2006; U.S. EPA 1991; ICFI. 1984; IARC. 1982; NIOSH.
1981a). Both processes mix preheated air with vaporized methanol, feed the gaseous mixture into a
reactor, cool the reactor products, and then separate the products through absorption towers and
distillation columns to recover an aqueous formaldehyde solution (Gerberich and Seaman. 2013;
NICNAS. 2006; ICFI. 1984). The silver-catalyst-based process uses a feed that is rich in methanol and
completely converts the oxygen while the metal-oxide-based process uses a feed that is lean in methanol
and completely converts the methanol. Both processes must keep the mixture of methanol and oxygen
outside of the flammable range. Approximately 70 percent of newly installed formaldehyde production
capacity uses the metal oxide process (Gerberich and Seaman. 2013). Methanol arrives at the facility in
tank trucks or railroad tank cars and is transferred to a large bulk storage tank, where it is then pumped
to a methanol vaporizer (NICNAS. 2006; Dunn et al.. 1983b; Dunn et al.. 1983a; Monsanto Research
Corp. 1981). The manufacture of formaldehyde is typically an enclosed continuous process.
A.2 Manufacturing - Importing
Import refers to the import of formaldehyde into the customs territory of the United States. This
condition of use includes loading/unloading and repackaging (but not transport) associated with the
import of formaldehyde. Commodity chemicals such as formaldehyde may be imported into the United
States in bulk via water, air, land, and intermodal shipments. These shipments take the form of
oceangoing chemical tankers, railcars, tank trucks, and intermodal tank containers. Common
formaldehyde grades include formulations of 37, 44, 50, and 56 by wt% (Krali. 2015; Gerberich and
Seaman. 2013; NIOSH. 1986; Dunn et al.. 1983b; Monsanto Research Corp. 1983; IARC. 1982;
NIOSH. 198 laV
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A.3 Processing - Reactant - Adhesives and Sealant Chemicals in: Plastic and
Resin Manufacturing; Wood Product Manufacturing; Paint and Coating
Manufacturing; Basic Organic Chemical Manufacturing
This COU refers to the use of a chemical substance in chemical reactions for the manufacturing of
another chemical substance or product. In this case, formaldehyde is used as a feedstock in the
production of another chemical substance in which formaldehyde is consumed during the chemical
reaction. This COU includes the use of formaldehyde in several sectors, including as an adhesive and
sealant chemical in plastic and resin manufacturing, wood product manufacturing, paint and coating
manufacturing, and basic organic chemical manufacturing.
The most common use of formaldehyde in processing as a reactant is in resin manufacturing. In the
manufacturing of resins using formaldehyde, formaldehyde arrives at the site in the form of formalin, a
solution that typically consists of 37 to 40 percent formaldehyde (NIOSH. 198Id). However, EPA
expects that the concentration of formaldehyde for each process where formaldehyde is processed under
processing as a reactant will vary depending on the desired final product. The processing typically
begins with the input components being charged into the reactor at concentrations and temperatures
necessary to meet customer specifications. The raw materials used in the reaction will vary depending
on the desired resin. As an example, raw materials for phenol formaldehyde resins may include
formalin, phenol, sodium hydroxide, concentrated sulfuric acid, hexamethylenetetramine (HMT),
ethanol, methanol, and xylene (NIOSH 1981c). Some examples of products produced in which
formaldehyde is consumed during the reaction include: urea-formaldehyde resins;
hexamethylenetetramine; phenol-formaldehyde resins; pentaerythritol; acetal resins; 1,4-butanediol;
melamine-formaldehyde resins; other acetylenic chemicals; chelating agents; urea-formaldehyde
concentrates; trimethylol propane; 4,4-methylenedianiline; acrylic esters; pyridine compounds, and
nitroparaffins.
A.4 Processing - Reactant - Intermediate in: Pesticide, Fertilizer, and Other
Agricultural Chemical Manufacturing; Petrochemical Manufacturing;
Soap, Cleaning Compound, and Toilet Preparation Manufacturing; Basic
Organic Chemical Manufacturing; Plastic Materials and Resin
Manufacturing; Adhesive Manufacturing; Chemical Product and
Preparation Manufacturing; Paper Manufacturing; Paint and Coating
Manufacturing; Plastic Products Manufacturing; Synthetic Rubber
Manufacturing; Wood Product Manufacturing; Construction;
Agriculture, Forestry, Fishing, and Hunting
This COU refers to the use of a chemical substance in chemical reactions for the manufacturing of
another chemical substance or product. In this case, formaldehyde is used as a feedstock or intermediate
in the production of another chemical product via a chemical reaction in which formaldehyde is
consumed to form the product, and that final product does not have any traces of formaldehyde. This
condition of use encompasses the use of formaldehyde as an intermediate in the following industrial
sectors: pesticide, fertilizer, and other agricultural chemical manufacturing; petrochemical
manufacturing; soap, cleaning compound, and toilet preparation manufacturing; basic organic chemical
manufacturing; plastic materials and resin manufacturing; adhesive manufacturing; chemical product
and preparation manufacturing; paper manufacturing; paint and coating manufacturing; plastic products
manufacturing; synthetic rubber manufacturing; wood product manufacturing; construction; agriculture,
forestry, fishing, and hunting.
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A public comment from The Fertilizer Institute states that the most common formaldehyde-based
reactant (FBR) used to produce urea is urea-formaldehyde concentrate (CAS No. 9011-05-6). The
typical concentration for this FBR is 60% formaldehyde, 25% urea, and 15% water. For the
manufacturing of formaldehyde-based fertilizers, FBRs are received onsite in stabilized water solutions
via tank trucks which are pumped into storage. The FBRs are often stored in bulk warehouses containing
up to 100,000 tons of urea. Slow-release urea solid fertilizer products are packaged in 25-1,000 kg bags,
and triazone fertilizer products are packaged in 275-gallon totes.
A.5 Processing - Reactant - Functional Fluid in: Oil and Gas Drilling,
Extraction, and Support Activities
This COU refers to the use of a chemical substance in chemical reactions for the manufacturing of
another chemical substance or product. In this case, formaldehyde is used as a feedstock in the
production of another chemical substance.
This COU is referring to the use of formaldehyde in the production of functional fluids for oil and gas
drilling activities. A functional fluid is a fluid which can be used for both open and closed systems. After
the reaction, it is expected that formaldehyde remains as a component of certain functional fluids in
hydraulic fluids used for oil and gas drilling activities.
A.6 Processing - Reactant - Processing Aids, Specific to Petroleum
Production in Basic Chemical Manufacturing
This COU refers to the use of a chemical substance in chemical reactions for the manufacturing of
another chemical substance or product. In this case, formaldehyde is used as a feedstock in the
production of another chemical product in which formaldehyde is consumed during the chemical
reaction.
This COU is referring to the use of formaldehyde in the production of products that are then used as a
processing aid during petroleum production for the manufacturing of other chemicals.
A. 7 Processing - Reactant - Bleaching Agent in Wood Product
Manufacturing
This COU refers to the use of a chemical substance in chemical reactions for the manufacturing of
another chemical substance or product. In this case, formaldehyde as a feedstock in the production of
another chemical product via a chemical reaction in which formaldehyde is consumed to form the
product.
This COU is referring to the use of formaldehyde in the production of bleaching aids for wood product
manufacturing. Wood bleaching is the process of treating wood and woody pulps with chemical agents
that contain formaldehyde to increase the brightness of the pulp by removing lignin.
This COU was not reported in the 2020 CDR.
A.8 Processing - Reactant - Agricultural Chemicals in Agriculture, Forestry,
Fishing, and Hunting
This COU refers to the use of a chemical substance in chemical reactions for the manufacturing of
another chemical substance or product. In this case, formaldehyde is used as a feedstock in the
production of another chemical product in which formaldehyde is consumed during the chemical
reaction. Use of formaldehyde in agricultural products accounts for approximately 2-5% percent of total
formaldehyde production volume.
This COU is referring to the use of formaldehyde as an intermediate in the production of agricultural
chemicals and includes the use of formaldehyde during the manufacturing of urea. Urea is primarily an
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agricultural product used in fertilizer mixtures and animal feed supplements. Formaldehyde is injected
into the urea product during the coating process and reacts to form methylenediurea, which is a
conditioning agent. Urea-formaldehyde is used in the manufacture of controlled-release fertilizers,
which release nutrients at a constant rate over time. End users of controlled-release fertilizers include
agricultural, horticultural, landscaping, and consumer markets. Urea-formaldehyde concentrates
comprise approximately 80% of the slow-release fertilizer market.
A.9 Processing - Incorporation into an Article - Finishing Agents in Textiles,
Apparel, and Leather Manufacturing
This COU refers to the preparation of an article, meaning formaldehyde becomes an integral component
of the article after its manufacture for distribution in commerce. In this case, formaldehyde is used as a
finishing agent in textile processing. Formaldehyde can be either used alone, together with other
reagents such as softeners or wetting agents, or in the form of simple formaldehyde derivatives (NIOSH.
1981b; Hovding. 1959). Resins containing formaldehyde are used as cross-linking agents and can impart
beneficial characteristics upon fabric such as wear and crease resistance, water repellency, increased
fabric resistance, and aiding in dye fixation (NICNAS. 2006; Corn well. 1988; NIOSH. 1984a. 1981b).
Textile finishing can be divided into three main steps: fabric pretreatment (e.g., washing, bleaching, de-
sizing); coloring; and functional finishing (OECD. 2004; Bendix Corp. 1979). Formaldehyde is only
included in the functional finishing. During the finishing process, resins containing formaldehyde are
combined with catalysts and cured in ovens at high temperatures to form the "permanent-press"
treatment of fabrics. Formaldehyde has been identified as a preservative, finishing agent, and fixing
agent in leather tanning (U.S. EPA. 2020b; Cuadros et al.. 2016; NICNAS. 2006; U.S. EPA. 2001).
Tanning is a general term for the processing steps involved in converting animal hides or skins to leather
(OECD. 2004). In the case of white sheepskin tanning, commercial grade formaldehyde (11%) is added
to the depickled skins in a drum and allowed to sit overnight (Hernon. 1981).
A. 10 Processing - Incorporation into an Article - Paint Additives and Coating
Additives Not Described by Other Categories in Transportation
Equipment Manufacturing (Including Aerospace)
This COU refers to the preparation of an article meaning formaldehyde becomes an integral component
of the article after its manufacture for distribution in commerce. In this case, the use of formaldehyde in
paints and coatings for transportation equipment manufacturing, including formaldehyde present in trace
amounts in raw materials used for adhesives and sealants in the aerospace industry (NASA. 2020; ACA.
2019; AIA. 2019). Formaldehyde is also in synthetic latex resins and is found in fluorescent pigments.
The concentration of formaldehyde in the final product may range from 0.1 to 1 percent, although
formulators expect the actual concentration of formaldehyde to be lower (ACA. 2019). However,
submitters in the 2020 CDR indicated 1 to 30 percent maximum concentration for two-component glues
(U.S. EPA. 2020a). A typical process begins with liquid formulations being manually poured from
transport containers directly into a coating reservoir (OECD. 2015b). Solid formulations received are
loaded directly into dispensing equipment. The application procedure depends on the type of adhesive or
sealant formulation and the type of substrate. Typically, the formulation is loaded into the application
reservoir or dispensing equipment and applied to the substrate via spray, roll, curtain, syringe, or bead
application.
According to a public comment, formaldehyde may also be present in trace amounts in most raw
materials used in paints and coatings with a range from 0.1 to 1 percent (EPA-HQ-OPPT-2018-0438-
0004) (ACA. 2019). A public comment indicates the use of formaldehyde in a wide range of coatings,
such as primers, topcoats, varnishes, lacquers, and specialty coatings (EPA-HQ-OPPT-2018-0438-0006)
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(AIA. 2019).
Spray application of paints and coatings containing formaldehyde are utilized in the automotive
refinishing industry (OECD. 2011a). Various coating products such as hardeners, reducers, activators,
atomizing agents, or colorants may be blended into their final formulations according to the paint
manufacturer's specifications before application.
A.ll Processing - Incorporation into an Article - Additive in Rubber Product
Manufacturing
This COU refers to the preparation of an article meaning formaldehyde becomes an integral component
of the article after its manufacture for distribution in commerce. In this case, formaldehyde and
formaldehyde resins have several uses in the rubber and elastomer manufacturing industry including as a
vulcanizing agent which is a cross-linking of rubber with sulfur to make a product stronger, as a
preservative and coagulant for rubber latex, as an anti-oxidizer and curing agent for synthetic rubber, as
a tackifier which makes the rubber more sticky to help with the binding process, and as a reinforcing
resin for other rubber-based materials (U.S. EPA. 2023; USTMA. 2020. 2019; Gunter. 1977; NIOSH.
1973). In tire manufacturing, formaldehyde-based resins are used as crosslinking agents or to build
adhesion between different tire components. Formaldehyde may also be in coatings on fabric belts
(USTMA. 2019).
During tire manufacturing, low levels of formaldehyde are present in reinforcing and tackifying resins
(USTMA. 2020. 2019). The formaldehyde resins are incorporated into the tire compound during mixing,
which may occur at tire manufacturing facilities or separate mixing facilities. According to a public
comment any formaldehyde present in the resins is expected to be fully consumed during curing
(USTMA. 2020. 2019; U.S. EPA. 1995).
Formaldehyde is also used during high-pressure hose manufacturing, which is used by the automotive,
oil, and farming industries (Gunter. 1977; NIOSH. 1973). During rubber hose manufacturing, rayon or
polyester cords are treated by a rewinder. The rewinding process involves dipping the cord into a
solution containing formaldehyde. After the cord is treated with formaldehyde, a rubber hose is fed into
a braiding machine. The braiding machine reinforces the rubber hose by braiding the treated cord around
the rubber hose (Gunter. 1977; NIOSH. 1973).
A.12 Processing - Incorporation into an Article - Adhesives and Sealant
Chemicals in Wood Product Manufacturing; Plastic Material and Resin
Manufacturing (Including Structural and Fireworthy Aerospace
Interiors); Construction (Including Roofing Materials); Paper
Manufacturing
This COU refers to the preparation of an article meaning formaldehyde becomes an integral component
of the article after its manufacture for distribution in commerce. In this case, formaldehyde resins are
incorporated into adhesives used to manufacture composite wood products (NICNAS. 2006; Van der
Wal. 1982). These products include but are not limited to particleboard, fiberboard, oriented strand
board, and plywood (Solenis. 2020; NICNAS. 2006; Van der Wal. 1982). Concentrations of
formaldehyde in the resins used to manufacture these products range from less than 0.2 to 0.5 percent.
The process of incorporating formaldehyde resins into wood products involves injecting the resins with
refined wood fiber, mixing, then rolling and pressing the wood product (NICNAS. 2006; Saary et al..
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2001; NZ DOH. 1981; Brevsse. 1980). Types of formaldehyde resins used include urea, phenol,
melamine, or a combination of these resins (NICNAS. 2006). In the case of plywood, the formaldehyde
resins are pumped into glue spreaders and applied to the veneer using rollers, which are then pressed
(NICNAS. 2006; Brevsse. 1980). The manufacture of compressed wood products is an automated
process (Sussell. 1995). Compressed wood products can be used in several construction applications,
such as residential buildings, commercial and industrial structures, furniture, and material handling such
as pallets (NICNAS. 2006; Sussell. 1995).
Formaldehyde is a constituent in pre-impregnated materials used to manufacture composite materials
such as fibrous insulation, asphalt roofing, and composite panels (ARMA. 2019; NAIMA. 2019;
NICNAS. 2006). Pre-impregnated materials include reinforcement fibers loaded with a partially cured
resin (AIA. 2024). Fiber glass and mineral wool building insulation products typically contain 3 to 6
percent by weight cured formaldehyde binder (NAIMA. 2019). During fiberglass or mineral wool
insulation manufacturing, aqueous solutions of formaldehyde resin are sprayed onto fibers. The fibers
are then sent to a curing oven, in which the binder is thermally set. According to public comment,
virtually all free formaldehyde content is eliminated during the curing process (EPA-HQ-OPPT-2018-
0438-0008).
Urea-formaldehyde resins are incorporated into fiberglass mats used for asphalt roofing (ARMA. 2019).
During the manufacture of fiberglass mats, a binder solution containing formaldehyde resin is uniformly
applied to the surface of fiberglass mats. A vacuum removes excess binder solution for re-use. The mat
is then passed through drying and curing ovens to remove moisture and set the binder (ARMA. 2019).
Asphalt roofing manufacturing typically involves the following processes: coating, mineral surfacing,
cooling, drying, product finishing, and packaging (ARMA. 2019; Apol and Okawa. 1977).
Finished fiberglass mats may be further incorporated into gypsum wallboard. During gypsum wallboard
production, a gypsum slurry is fed between continuous layers of fiberglass mats to create reinforced
boards. The gypsum slurry recrystallizes as the reinforced boards move down a conveyor belt. The
boards are then cut to length and sent through dryers.
Formaldehyde resins are incorporated into adhesives and sizing agents used in the manufacturing and
finishing of paper products (Robinson et al.. 1986). Paper manufacturing often takes place in the same
plant where pulp is produced (Robinson et al.. 1986). The pulp product is mixed with water and
additives such as sizing agents which can include formaldehyde compounds. The pulp slurry is then
formed into sheets, then dried and coated. Formaldehyde can also be present in the final coating applied
to the paper product (Apol and Thoburn. 1986).
Formaldehyde is also a raw material in the manufacturing of polyoxymethylene (POM). POM is a
specialized, engineered polymer in which formaldehyde is used as an upstream ingredient and can be
found in a wide range of automobile products including interiors such as seatbelts, buckles, door trims,
and dashboards. In general, for the manufacturing of plastic articles, polymer resin is typically received
at the compounding sites from the resin manufacturer in the form of pellets. The plastic resins are then
typically heated and formed into products through extrusion, thermoforming, compression molding,
calendaring, and encapsulation. After the heating and forming processes, the plastic may be further
processed and molded into the finished product. These molding processes can include injection molding,
transfer molding, compression molding, blow molding, and rotational molding. The final plastic product
manufacturing operations are usually finishing and trimming. Solid waste from this process is typically
sent to landfill or incineration (U.S. EPA. 2004a).
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A.13 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Petrochemical Manufacturing, Petroleum, Lubricating Oil and
Grease Manufacturing; Fuel and Fuel Additives; Lubricant and
Lubricant Additives; Basic Organic Chemical Manufacturing; and
Petroleum and Coal Products Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is used in the manufacturing of various
petrochemicals, petroleum, and coal products, lubricating oils and greases, and organic chemicals.
A.14 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Asphalt, Paving, Roofing, and Coating Materials
Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into asphalt, paving,
roofing, and coating material products. In addition, this COU includes the incorporation of
formaldehyde into a urea-formaldehyde resin that is used in the manufacturing of glass fiber roofing
mats in order to bind the fiberglass fibers. Formaldehyde is also incorporated into hot asphalt products
used for paving and as a base structure for roofing mats (EPA-HQ-QPPT-2023-0613-0241).
A.15 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Solvents (Which Become Part of a Product Formulation or
Mixture) in Paint and Coating Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into a variety of paints and
coatings, including lacquers, stains, varnishes, primers, topcoats, and specialty coatings. Functional uses
of formaldehyde in the manufacture of paints and coatings include as an ion exchange agent and solvent
(which become part of the final product).
A. 16 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Processing Aids, Specific to Petroleum Production in: Oil and
Gas Drilling, Extraction, and Support Activities; Chemical Product and
Preparation Manufacturing; and Basic Inorganic Chemical
Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into products that then are
used as processing aids specific to petroleum production such as oil and gas drilling, extraction, and
support activities, chemical product and preparation manufacturing, and basic inorganic chemical
manufacturing. Processing aid means any chemical substance used to aid in the manufacture or synthesis
of another chemical substance such that it comes into contact with the product during manufacture but is
not intended to remain with or become part of the final product or mixture. Formaldehyde is also
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incorporated into corrosion inhibitors and anti-scaling agents for oil and gas drilling, extraction, and
other related support activities.
A.17 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Paint Additives and Coating Additives Not Described by Other
Categories in: Paint and Coating Manufacturing; Plastic Material and
Resin Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into a variety of paints and
coatings, including lacquers, stains, varnishes, primers, topcoats, and specialty coatings. Functional uses
of formaldehyde in the manufacture of paints and coatings include: as a paint additive and coating
additive, as a hardener, as a corrosion inhibitor, and as a diluent.
A. 18 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Intermediate in: Basic Chemical Manufacturing; Chemical
Product and Preparation Manufacturing; Plastic Material and Resin
Manufacturing; Oil and Gas Drilling, Extraction, and Support Activities;
Wholesale and Retail Trade
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. An intermediate means any chemical substance that is consumed, in
whole or in part, in chemical reactions used for the intentional manufacture of other chemical substances
or mixtures, or that is intentionally present for the purpose of altering the rates of such chemical
reactions. In this case, formaldehyde is incorporated into an intermediate product that then is used in the
manufacturing of other chemical substances, plastic and resin manufacturing, and for use in oil and gas
drilling activities.
A. 19 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Solid Separation Agents in Miscellaneous Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into a solid separation
agent product. The formaldehyde-containing product then is added to a chemical mixture in which solid
materials are then separated from that mixture in order to recover certain substances or reduce waste.
This COU was not reported in the 2016 or 2020 CDR.
A.20 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Agricultural Chemicals (nonpesticidal) in: Agriculture,
Forestry, Fishing, and Hunting; Pesticide, Fertilizer, and Agricultural
Chemical Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into nonpesticidal
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agricultural chemicals for uses in agriculture, forestry, fishing, and hunting, and pesticide, fertilizer, and
agricultural chemical manufacturing.
Formaldehyde is used in agricultural products which accounts for approximately 2-5% percent of total
formaldehyde consumption. In this case, formaldehyde is incorporated into formulation, mixture, or
reaction product, that then is used in the manufacturing of fertilizers.
A.21 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Surface Active Agents in Plastic Material and Resin
Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into a surface-active agent
for plastic and resin manufacturing. The surface-active agent containing formaldehyde is added during
the manufacturing process to decreases the surface tension.
A.22 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Ion Exchange Agents in Adhesive Manufacturing and Paint
and Coating Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is incorporated into an ion exchange agent
for adhesive, paint, and coating manufacturing. Formaldehyde is used in liquid solutions in order to
absorb positively or negatively charged ions from an aqueous electrolyte solution and, simultaneously,
release other ions of equivalent amount into the aqueous solution.
A.23 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Lubricant and Lubricant Additive in Adhesive Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is used as a lubricant in adhesive
manufacturing.
A.24 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Plating Agents and Surface Treating Agents in Chemical
Product and Preparation Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is used as a plating agent and surface
treating agent in chemical product and preparation manufacturing. Formaldehyde is the most widely
employed reducing agent in electroless copper plating applications. Formaldehyde is also used as a
surface coating and treatment of metals, such as chromatisizing agents, and as a cooling agent for metal
processing.
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A.25 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Soap, Cleaning Compound, and Toilet Preparation
Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is used as a deodorizer for soap and
cleaning chemicals used for toilet bowl cleaners and drain cleaners.
A.26 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Laboratory Chemicals
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is added to other substances to produce a
laboratory chemical in the medical diagnostic/pathology profession in which formaldehyde acts as a
form of fixative. Formaldehyde for laboratory use is typically used at a concentration of at least 1 but
less than 30% by weight. Formaldehyde can be used in downstream uses in commercial laboratories for
microscope slide preparation and is used to bind proteins in order to make cells or tissues more
structurally solid in the short term. For example, an animal cell may be mobile on a glass slide so a
fixative that contains formaldehyde could be applied to that slide, so the cell is no longer mobile. Use for
slide preparation could potentially have a short-term fixative (non-preservation) purpose if there is not
also an intent to preserve the tissue for later analysis.
A.27 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Adhesive and Sealant Chemical in Adhesive Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde's functional use in adhesive and sealant
chemical can be as a hardener, as a binding agent, as an ion exchange agent, a lubricant and lubricant
additive.
A.28 Processing - Incorporation into a Formulation, Mixture, or Reaction
Product - Bleaching Agents in Textile, Apparel, and Leather
Manufacturing
This COU refers to the preparation of a product in which formaldehyde is added into a formulation,
mixture, or a reaction product after its manufacture, but prior to further distribution in commerce of the
product containing formaldehyde. In this case, formaldehyde is used as a part of another chemical
substance to whiten and brighten cloth fibers. Various concentrations of these chemicals containing
formaldehyde may be used to obtain the desired brightness of the final cloth.
A.29 Processing - Repackaging - Sales to Distributors for Laboratory
Chemicals
Repackaging refers to the preparation of formaldehyde for distribution in commerce in a different form,
state, or quantity than originally received or stored for use as laboratory chemical. This COU can be
undertaken by various industrial sectors, including chemical product and preparation manufacturing,
wholesale and retail trade, and laboratory chemicals manufacturing.
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Domestically manufactured commodity chemicals may be shipped within the United States in liquid
cargo barges, railcars, tank trucks, tank containers, intermediate bulk containers (IBCs)/totes, and drums.
Both imported and domestically manufactured commodity chemicals may be repackaged by wholesalers
for resale, such as repackaging bulk packaging into drums or bottles. The type and size of the container
will vary depending on customer requirements. In some cases, quality control samples may be taken at
import and repackaging sites for analyses. Some import facilities may only serve as storage and
distribution locations, and repackaging/sampling may not occur at all import facilities. This COU
includes the transferring of formaldehyde from a bulk container into smaller containers for distribution
to professional laboratories. Most repackaging of formalin or product containing formaldehyde are from
200 L drums to smaller containers, such as 5 L and 20 L containers. They are decanted into smaller
containers either through a pump (enclosed process) or fed via gravity.
This COU would not apply to the relabeling or redistribution of a chemical substance without removing
the chemical substance from the original container it was supplied in.
A.30 Processing - Recycling
This COU refers to the process of treating generated waste streams (i.e., which would otherwise be
disposed of as waste), containing formaldehyde, that are collected, either on-site or transported to a
third-party site, for commercial purpose.
Formaldehyde may be present during the process of recycling electronic waste (e-waste) as the polymer
phenol formaldehyde (PF) is used in electronic applications^ The recycling process of e-waste typically
begins with the recovery of waste from different storage facilities. The waste then usually undergoes a
pretreatment technology consisting of washing, size reduction, sorting, and melt filtration. The sorting of
plastics is the typical next step in the process and may use separation techniques such as density-based
sorting, electrostatic sorting, and others. The formal recycling process can consist of either a mechanical,
chemical or thermal recycling process (Flaris et al.. 2009).
A.31 Distribution in Commerce
For purposes of assessment in this risk evaluation, distribution in commerce consists of the
transportation associated with the moving of formaldehyde-containing products between sites
manufacturing, processing or recycling formaldehyde-containing products, or to final use sites, or for
final disposal of formaldehyde-containing products. In this risk evaluation, EPA has assessed the
exposure from temporary storage and warehousing of formaldehyde during distribution for commerce.
More broadly under TSCA, "distribution in commerce" and "distribute in commerce" are defined under
TSCA section 3(5). EPA anticipates that formaldehyde and its products are distributed throughout
commerce for the COUs evaluated throughout other lifecycle stages assessed in this evaluation. The
physical form of formaldehyde in transit can vary amongst the different COUs. Domestically
manufactured commodity chemicals, such as formaldehyde, may be shipped within the United States in
liquid cargo barges, railcars, tank trucks, tank containers, intermediate bulk containers (IBCs)/totes, and
drums.
A.32 Industrial Use - Non-Incorporative Activities - Process Aid in: Oil and
Gas Drilling, Extraction, and Support Activities; Process Aid Specific to
Petroleum Production, Hydraulic Fracturing
This COU refers to formaldehyde use in non-incorporative activities, such as a chemical processing aid
or manufacturing aid, in various industrial sectors oil and gas drilling and related support activities as
well as petroleum production and hydraulic fracturing. A processing aid is a chemical added to a
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chemical mixture that is used to improve the processing of the chemical mixture but does not become
part of the reaction product and not intended to affect the function of a substance or article created.
Traditional oil extraction is comprised of four main steps: (1) exploration, (2) well development, (3)
petroleum production, and (4) site abandonment. The main activities typically involved in petroleum
production are bringing the fluid to the surface and separating each component in the extracted fluid.
The extracted mixture is typically first processed to remove the gaseous components, followed by the
removal of solids from the resulting emulsion. The remaining oil-water emulsion is then further treated
to separate the oil. Petroleum production is typically divided into three stages: primary production,
secondary recovery, and tertiary recovery. Primary production is the first stage of production where
natural well pressure is used to recover oil. This segment of the production process usually only utilizes
maintenance chemicals, such as corrosion inhibitors which contain formaldehyde, to protect metallic
components of the piping and well structure. After primary production is no longer feasible, secondary
recovery is then employed. This process typically involves the injection of water into the well to re-
pressurize the reservoir. The only chemicals in this stage of the process are those which remain from
primary production. Tertiary recovery is the final stage of petroleum production which is typically used
only when the other methods have been exhausted. The chemicals involved in this process may include
surfactants, friction reducers, gases, acids, and proppants. The goal of this stage is to modify the
physical characteristics of the crude oil to make it more conducive to flow (OECD. 2012).
Formaldehyde is present in hydraulic fracturing fluid additives as an inhibitor aid, corrosion inhibitor,
friction reducer, surfactant, acid, breaker, gelling agent, and crosslinker. (GWPC and IOGCC. 2022).
Hydraulic fracturing stimulates an existing oil or gas well by injecting a pressurized fluid containing
chemical additives into the well (U.S. EPA. 2022). Hydraulic fracturing fluids typically arrive as a liquid
in totes, drums, or bulk containers these formulations are usually charged to a temporary storage tank, or
fracturing fluid additives are charged to a mixing tank with other additives to formulate the final
fracturing fluid that is injected into the well. Once fracturing fluid is formulated to the desired
specification, the injection process may begin(U.S. EPA 2022). The hydraulic fracturing fluid is
pumped into a wellbore where it cracks and permeates the rock below. A portion of the fracturing fluid,
including any chemical additives such as formaldehyde, may remain in the underground shale
formation. The remaining fluid will return to the surface in water that flows back to the surface from the
well. This is known as flow-back water. Initially, this flow-back water is mostly fracturing fluid, which
includes chemical additives, but as time goes on, it becomes water produced from the rock formation.
Wastewater containing chemical additives such as formaldehyde is usually stored and accumulated at
the surface for eventual reuse or disposal. Typical storage facilities include open-air impoundments and
closed containers. This wastewater is collected and may be taken to disposal wells, recyclers,
wastewater treatment plants (on- or off-site), or in some cases the water may be left in pits to evaporate
or infiltrate (U.S. EPA 2022).
A.33 Industrial Use - Non-Incorporative Activities - Used in: Construction
This COU refers to formaldehyde use in non-incorporative activities, such as a chemical processing aid
or manufacturing aid, in construction. A processing or manufacturing aid is a chemical added to a
chemical mixture that is used to improve the processing of the chemical mixture or a manufacturing
process but does not become part of the reaction product and not intended to affect the function of a
substance or article created.
In construction, formaldehyde is used to manufacture an end product or article which does not contain
formaldehyde. These industrial uses can include building insulation, concrete and cement, glass
products, laminates, furniture, and other miscellaneous construction materials including tiles, wall
coverings, bricklaying, plumbing components, and plastic materials.
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A.34 Industrial Use - Non-Incorporative Activities - Oxidizing/ Reducing
Agent; Processing Aids, Not Otherwise Listed
This COU refers to formaldehyde use in non-incorporative activities, such as a chemical processing aid
or manufacturing aid, in various industrial operations not covered by other COUs. A processing aid is a
chemical added to a chemical mixture that is used to improve the processing of the chemical mixture but
does not become part of the reaction product and not intended to affect the function of a substance or
article created.
This COU includes the use of formaldehyde as a reducing agent in the electroless copper plating process
to reduce copper ions (IPC International 2019). The electroless copper plating process includes hole
formation, hole wall prep, electroless copper hole wall plating, and electrolytic hole wall plating (IPC
International 2019). Formaldehyde is used in the semiconductor manufacturing industry as a processing
aid for metal plating formulations (SIA. 2020). Formaldehyde may be present in semiconductor products
as a byproduct in concentrations less than 10 ppm. Semiconductor device fabrication creates integrated
circuits present in electronic devices. The fabrication process starts with a semiconductor material wafer.
During the photolithography step, the wafer is coated with photoresist material and covered with a mask
that defines patterns to be retained or removed in the following processing steps. Formaldehyde may be
present in the photoresist material utilized in this step of the process (SIA. 2020).
A.35 Industrial Use - Industrial Products - Paints and Coatings; Adhesives
and Sealants; Lubricants
This COU refers to formaldehyde used as a component of industrial paints and coatings, adhesives and
sealants, and lubricants. Meaning the use of formaldehyde after it has already been incorporated into a
paint or coating product or mixture, as opposed to when it is used upstream (e.g., when formaldehyde is
processed into the paint or coating, adhesive and sealant formulations).
This COU includes the use of formaldehyde-based phenol resins as liquid binding agents to coat sand
that is then used in the core making in the foundry industry (Lofstedt et al. 201 lb; NTP. 2010; Oliva-
Teles et al. 2009; NICNAS. 2006; RTI. 1980; Kominsky and Stroman. 1977). Castings produced by
foundries are used in a wide range of manufactured products. These include vehicles, industrial
production equipment, water and wastewater systems, various piping and valves, railcars and
locomotives, military equipment and vehicles, and household appliances. The resins generally contain
<0.1 to 1 percent free formaldehyde (EPA-HQ-QPPT-2023-0613-0234). The formaldehyde resin arrives
at sand coating sites in large drums. The resin is pumped into a mixer and typically mixed with silica
sand for 5 minutes. Some sites may decant the resin manually from drums into a measuring cup, then
pour it into the mixer. After mixing, the coated sands are decanted into bags for core-making at foundry
sites. The sand coating is a batch operation, and the frequency may vary depending on the site.
At foundry sites, iron castings are produced for the manufacture of metal products (Lofstedt et al.
2011b; NICNAS. 2006). The coated sand arrives in bags from the sand coating sites and is used to make
solid shape "cores," via a binding system. The cores determine the internal cavities of the casting. Cores
are primarily produced by hot or warm box technology using urea formaldehyde resin. The sand coated
with resin is blown into a hot mold, where the formaldehyde resin melts and acts as a binding agent to
form the core. At larger operations, sand coating and core making may take place in an enclosed system,
where a set dosage of formaldehyde resin is automatically supplied to core-making machines (Lofstedt
et al. 2011b; Lofstedt et al. 2011a; Lofstedt et al.. 2009; NICNAS. 2006; NIOSH. 1993).
The urethane cold box process is another widely used process in foundries in the automotive,
transportation, mining, agricultural, and military sectors. This process utilizes liquid phenol-
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formaldehyde resins. Formaldehyde-containing resins are also used in the following foundry processes:
urethane no bake, shell resins, phenolic ester no bake, furan no bake, warm box/hot box, and inorganic
cold box, and alkyd no bake. These resins typically contain < 0.1 to 1 percent free formaldehyde (EPA-
HO-QPPT-2023-0613-0234).
This COU also includes activities identified by the U.S. Department of Defense.
This condition of use was not reported in the 2016 or 2020 CDR.
A.36 Industrial Use - Aerospace Use in: Paints and Coatings; Adhesives and
Sealants; Lubricants; and Foam Insulation
This COU refers to formaldehyde used as a component of industrial paints and coatings, adhesives and
sealants, lubricants, and foam insulation used in aerospace applications. Meaning the use of
formaldehyde after it has already been incorporated into a paint or coating product or mixture, as
opposed to when it is used upstream (e.g., when formaldehyde is processed into the paint or coating,
adhesive and sealant formulations).
This COU includes the use of formaldehyde in the manufacture, operations, and maintenance of
aerospace products, specifically in adhesives and sealants for the purpose of sealing specialized fuel
tanks. Other activities include formaldehyde in graphite paste, electrical insulators, marking inks, and
epoxy and phenolic resins used for the assembly of pre-impregnated fiber composites. Formaldehyde is
also in broad uses of coatings such as primers, polyurethane topcoats, adhesive bound primers, wash
primers, and other specialty coatings applied to aerospace products such as anti-friction coatings and
varnish, cleaners, sheet molding compounds, a brazing alloy protective coating, phenolic fillers, landing
gear shock strut fluid, chemical processing agents (including a bath stabilizer, reducing agent, photo
resist, calibration/indicator standards), and potting compounds for electronic assemblies. Formaldehyde
is also used in the manufacture, operations, and maintenance of aerospace products in lubricants which
can include dry film lubricants and lubricating oil (EPA-HQ-QPPT-2023-0613-0199).
Finally, formaldehyde is present in foam insulation to protect and completely cover specific, critical
components of a rocket. Referred to as a 'close out' foam because it completely seals these components
from the extreme temperatures before, during, and after a launch into space, this foam insulation is
manually applied via a spray application.
A.37 Commercial Use - Chemical Substances in Furnishings Treatment/Care
Products - Floor Coverings; Foam Seating and Bedding Products;
Furniture and Furnishings Including Stone, Plaster, Cement, Glass and
Ceramic Articles; Metal Articles; or Rubber Articles; Cleaning and
Furniture Care Products; Leather Conditioner; Leather Tanning, Dye,
Finishing Impregnation and Care Products; Textile (Fabric) Dyes;
Textile Finishing and Impregnating/Surface Treatment Products
This COU is referring to the commercial use of formaldehyde in furnishings treatment and care
products. Meaning the use of formaldehyde-containing furnishings treatment and care products in a
commercial setting, such as a business or at a job site, as opposed to upstream use of formaldehyde (e.g.,
when formaldehyde containing products are used in the manufacturing of the treatment products) or use
in an industrial setting.
This COU includes several uses of formaldehyde in furniture and furnishings, included the production of
wood-based and composite panels. Formaldehyde-based resins are used as adhesives in the production
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of wood-based and composite panels including particleboards, medium-density fiberboard (MDF),
oriented strand board (OSB), plywood, and blockboards (FWIC. 2020; Solenis. 2020; Offermann. 2017;
Kim. 2010; NICNAS. 2006). Wood panel products may be used for shelving, furniture, doors, cabinets,
and flooring. Wood panel products are then used for shelving, furniture, doors, cabinets, and flooring.
A.38 Commercial Use - Chemical Substances in Treatment Products - Water
Treatment Products
This COU is referring to the commercial use of formaldehyde in water treatment products. Meaning the
use of formaldehyde-containing water treatment products in a commercial setting, such as a business or
at a job site, as opposed to upstream use of formaldehyde (e.g., when formaldehyde containing products
are used in the manufacturing of the treatment products) or use in an industrial setting.
Formaldehyde is used in water testing kits and as a waste treatment liquid chemical used in wastewater
treatment facilities.
Examples of CDR Submissions
In the 2016 CDR cycle, two reporters indicated the commercial use of formaldehyde as a liquid in water
treatment products. One facility reported 6 percent of its PV towards this use with a formaldehyde
concentration of less than 1 percent by weight. The other facility reported 28 percent of its PV with a
concentration of 1 to less than 30 percent by weight (U.S. EPA. 2016).
This COU was not reported in the 2020 CDR cycle.
A.39 Commercial Use - Chemical Substances in Treatment/Care Products -
Laundry and Dishwashing Products
This COU is referring to the commercial use of formaldehyde in laundry and dishwashing products.
Meaning the use of formaldehyde-containing laundry and dishwashing products in a commercial setting,
such as a business or at a job site, as opposed to upstream use of formaldehyde (e.g., when formaldehyde
containing products are used in the manufacturing of the treatment products) or use in an industrial
setting.
Formaldehyde is used in liquid laundry detergent and fabric softener for laundry facilities in industrial
and institutional settings (OECD. 2011b). Industrial laundries wash soiled laundry received from
hospitals, repair shops, doctor's offices, and other customers. Institutional laundries are located within a
hospital, nursing home, hotel, or other institutional facilities (OECD. 2011b). Industrial laundry
detergents typically arrive as a liquid or powder in drums, totes, or bulk tanker trucks.
This COU was not reported in the 2016 or 2020 CDR cycles.
A.40 Commercial Use - Chemical Substances in Construction, Paint,
Electrical, and Metal Products - Adhesives and Sealants; Paint and
Coatings
This COU is referring to the commercial use of formaldehyde in adhesives, sealants, paint and coatings
products. Meaning the use of formaldehyde-containing adhesives, sealants, paint and coatings products
in a commercial setting, such as a business or at a job site, as opposed to upstream use of formaldehyde
(e.g., when formaldehyde containing products are used in the manufacturing of the construction
products) or use in an industrial setting.
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Formaldehyde is used in commercial adhesive and sealant products, including craft glues, wood glues,
caulking and putty, tile grout and sealer, spackle, and other construction adhesives. Formaldehyde is also
used in a variety of paints and coatings, including lacquers, stains, varnishes, primers, topcoats, and
specialty coatings.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.41 Commercial Use - Chemical Substances in Construction, Paint,
Electrical, and Metal Products - Construction and Building Materials
Covering Large Surface Areas, Including Wood Articles; Construction
and Building Materials Covering Large Surface Areas, Including Paper
Articles; Metal Articles; Stone, Plaster, Cement, Glass and Ceramic
Articles
This COU is referring to the commercial use of formaldehyde in furnishing treatment and care products.
Meaning the use of formaldehyde-containing furnishing treatment and care products in a commercial
setting, such as a business or at a job site, as opposed to upstream use of formaldehyde (e.g., when
formaldehyde containing products are used in the manufacturing of the treatment products) or use in an
industrial setting.
Formaldehyde-based resins are used as adhesives in the production of wood-based and composite panels
including particleboards, medium-density fiberboard (MDF), oriented strand board (OSB), plywood, and
blockboards. Plywood is used in several commercial applications, such as the construction of residential,
commercial, or industrial structures, building components for homes or other structures, and material
handling such as pallets. Wooden boards are cut to size on-site using a circular saw, then fitted and
sanded before installation. The lifespan of plywood, veneers, and wood paneling typically ranges from
20-100 years before demolition is required.
Formaldehyde resins may also be present in fiberglass insulation and urea-formaldehyde foam insulation
(NAIMA. 2019; Rossiter and Mathev. 1985; Enviro Control Inc.. 1983; NIOSFt. 1982c. 1980). Final
concentrations of formaldehyde in fiberglass insulation may be negligible.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.42 Commercial Use - Chemical Substances in Electrical Products -
Machinery, Mechanical Appliances, Electrical/Electronic Articles; Other
Machinery, Mechanical Appliances, Electronic/Electronic articles
This COU is referring to the commercial use of formaldehyde in electrical products. Meaning the use of
formaldehyde-containing electrical products in a commercial setting, such as a business or at a job site,
as opposed to upstream use of formaldehyde (e.g., when formaldehyde containing products are used in
the manufacturing of the electrical products) or use in an industrial setting.
Formaldehyde is found in numerous electrical and electronic products, including in printed circuit board
materials and in appliances, electric controls, telephones, electrical switches, circuit breakers, and
virtually all electronic products (Schripp and Wensing. 2009; LaDou. 2006). Electrical and electronic
products may be used in a variety of occupational settings, such as repair shops, office buildings, copy
centers, and electronic waste recycling centers ("Vicente et al.. 2017; Schripp and Wensing. 2009;
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Klincewicz and Reh. 1989). The concentration of formaldehyde in electronic products is unknown;
although, public comments report a negligible amount of formaldehyde in electronics (IPC International
2020; SIA. 2020V
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.43 Commercial Use - Chemical Substances in Metal Products -
Construction and Building Materials Covering Large Surface Areas,
Including Metal Articles
This COU is referring to the commercial use of formaldehyde in metal products. Meaning the use of
formaldehyde-containing metal products in a commercial setting, such as a business or at a job site, as
opposed to upstream use of formaldehyde (e.g., when formaldehyde containing products are used in the
manufacturing of the metal products) or use in an industrial setting.
Formaldehyde and formaldehyde resins are found in metal products and fabricated metal products,
including metal finishings such as metal hardware like screws, nails, and bolts. Formaldehyde is also
used in the surface coating of certain metal products.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.44 Commercial Use - Chemical Substances in Automotive and Fuel
Products - Automotive Articles and Automotive Care Products;
Lubricants and Greases; Fuels and Related Products
This COU is referring to the commercial use of formaldehyde in automotive and fuel products. Meaning
the use of formaldehyde-containing automotive and fuel products in a commercial setting, such as a
business or at a job site, as opposed to upstream use of formaldehyde (e.g., when formaldehyde
containing products are used in the manufacturing of the automotive products) or use in an industrial
setting.
Formaldehyde and formaldehyde resins are found in a range of automotive products such as interior
molded components, under-the-hood components, exterior primers and paints, tire-cord adhesives, brake
pads and linings, clutch facings, automatic transmission components, and fuel system components. For
automotive care products such as waxes and polishes, they may be applied directly onto the car or
application equipment (e.g., cloths, buffer pads), or they may be diluted with water in a bucket before
use. For the interior of the vehicle detailers may apply a protective coating to vinyl or leather surfaces by
wiping the coating onto surfaces and removing excess coating with cloths. Carpet and upholstery are
cleaned by pre-treating stains, then using portable carpet cleaning machines.
Formaldehyde is present in lubricants that may be used in the automotive industry (NICNAS. 2006). A
lubricant is defined as a material used to reduce friction between surfaces in relative motion with each
other (OECD. 2020). In the automotive industry, lubricants are used in gasoline and diesel engines.
EPA expects that these products are likely to be used in both commercial and consumer applications.
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A.45 Commercial Use - Chemical Substances in Agriculture Use Products -
Lawn and Garden Products
This COU is referring to the commercial use of formaldehyde in agricultural use products. Meaning the
use of formaldehyde-containing agricultural products in a commercial setting, such as a business or at a
job site, as opposed to upstream use of formaldehyde (e.g., when formaldehyde containing products are
used in the manufacturing of the agricultural products) or use in an industrial setting.
Formaldehyde is used in the production of three type of fertilizers: solid urea, slow-release urea solid
fertilizer, or slow-release urea liquid fertilizers. In both products, formaldehyde is used as a
reactant/intermediate in the process with only impurity levels of formaldehyde in fertilizer products.
Urea-formaldehyde is found in controlled-release fertilizers used in agricultural, horticultural,
landscaping, and consumer markets (ECHA. 2019). The application depends on a variety of factors
including crop type, soil type, and climate. Common application techniques include surface
broadcasting, incorporation into the soil using attachments to plow, and injection of liquid/gaseous
formulations by pumping through cultivator knives (Taylor. 2004). Dry granulated formaldehyde
fertilizers are either broadcast or suspended in water and root-zone injected or spray-applied (Koch Turf
2016).
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.46 Commercial Use - Chemical Substances in Outdoor Use Products -
Explosive Material
This COU is referring to the commercial use of formaldehyde in explosive material products. Meaning
the use of formaldehyde-containing explosive material products in a commercial setting, such as a
business or at a job site, as opposed to upstream use of formaldehyde (e.g., when formaldehyde
containing products are used in the manufacturing of the explosive materials) or use in an industrial
setting.
Formaldehyde is found in explosive materials such as ground-level pyrotechnics (Croteau et al.. 2010).
Explosive materials are intended to be used when a worker conducts outdoor pyrotechnic performances.
The explosive material is ignited, undergoes a reaction, and explodes (Croteau et al.. 2010).
This COU also includes activities identified by the U.S. Department of Defense.
This use was not reported in the 2020 CDR.
A.47 Commercial Use - Chemical Substances in Packaging, Paper, Plastic,
Hobby Products - Paper Products; Plastic and Rubber Products; Toys,
Playground, and Sporting Equipment
This COU is referring to the commercial use of formaldehyde in packaging, paper, plastic, hobby
products, toys, playground equipment, and sporting equipment. Meaning the use of these formaldehyde-
containing products and articles in a commercial setting, such as a business or at a job site, as opposed to
upstream use of formaldehyde (e.g., when formaldehyde containing products are used in the
manufacturing of these materials) or use in an industrial setting.
Formaldehyde and formaldehyde resins are found in pulp and paper products such as paper, cardboard,
wallpaper, and abrasive paper, such as sandpaper, including certain coatings in paper and cardboard
(ACC. 2019). Formaldehyde has been identified in carbonless copy paper which may be used in office
settings, educational supply stores, and printing shops (NIOSH. 2000; Zimmer and Hadwen. 1993;
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NIOSH. 1984b). Formaldehyde can be found in certain plastics used to manufacture toys, playground
equipment, and sporting equipment.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.48 Commercial Use - Chemical Substances in Packaging, Paper, Plastic,
Hobby Products - Arts, Crafts, and Hobby Materials
This COU is referring to the commercial use of formaldehyde in arts, crafts, and hobby products.
Meaning the use of formaldehyde-containing arts, crafts, and hobby products in a commercial setting,
such as a business or at a job site, as opposed to upstream use of formaldehyde (e.g., when formaldehyde
containing products are used in the manufacturing of these materials) or use in an industrial setting.
Formaldehyde can be found in colorants, pigments, and dyes in children's arts and craft supplies and
needlework supplies. Paints, coatings, and adhesives are applied manually by brush, roller, or spray onto
the substrate. Following application, the substrate is cured or dried before use. Formaldehyde can also be
found in other hobby materials such as colored paper, cardboard, small woodworking crafts, hobby
glues, and common arts and craft store items. EPA expects that these products would be used by
commercial hobbyists who are using these products to create saleable goods.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.49 Commercial Use - Chemical Substances in Packaging, Paper, Plastic,
Hobby Products - Ink, Toner, and Colorant Products; Photographic
Supplies
This COU is referring to the commercial use of formaldehyde in ink, toner, and colorant products as
well as photographic supplies. Meaning the use of formaldehyde-containing ink, toner, colorant, and
photographic products in a commercial setting, such as a business or at a job site, as opposed to
upstream use of formaldehyde (e.g., when formaldehyde containing products are used in the
manufacturing of these materials) or use in an industrial setting.
Phenol-formaldehyde based resins are found in printing ink, toner, and colorants. Formaldehyde can also
be used as a photochemical agent, a reprographic agent, a stopping material, a developer, a sensitizer
(photo conductor), a hardener, and a component of printing and writing inks. Formaldehyde is a
component of printing inks, which may include letterpress, offset, lithographic, inkjet, and flexographic
inks (U.S. EPA 2020b. 2010; Tuomi et al.. 2000). The inks may be used for newspapers, books,
labeling, and packaging. Printing activities may be categorized by the following processes: lithography,
gravure, flexography, letterpress, digital, and screen-printing, with lithography being the most used
(U.S. EPA. 2010).
Formaldehyde has been identified as a component in photographic film processing (Eastman Kodak.
2009; NICNAS. 2006; NIOSH. 1982a. 1974). Formaldehyde is used as a preservative, stabilizer,
replenisher, and hardener in final baths to prevent deterioration of image quality and damage to film
coatings (NICNAS. 2006).
Commercial film processing sites typically use enclosed machines with a final bath tank specifically for
formaldehyde solutions (NICNAS. 2006). Film development is typically done via a batch process
(NICNAS. 2006). The final product is transferred to containers and dispatched to customers. The
concentration of formaldehyde in the end product is typically 10.4 percent (NICNAS. 2006).
EPA expects that these products are likely to be used in both commercial and consumer applications.
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A.50 Commercial Use - Chemical Substances in Products Not Described by
Other Codes - Laboratory Chemicals
This COU is referring to the commercial use of formaldehyde in laboratory chemicals. Meaning the use
of formaldehyde in a commercial or industrial laboratory setting.
Formaldehyde may be used as a fixative in forensic, pathology laboratories, other medical-related
laboratories, and aerospace-related laboratories (Bruno et al.. 2018; NICNAS. 2006). Formaldehyde
used in laboratories is often a neutral buffered formalin which can contain up to a range of 2.5 to 50
percent formaldehyde, with a mode of < 20 percent. (Bruno et al.. 2018; Xu and Stewart. 2016; Sancini
et al.. 2014; Viegas and Prista. 2010; NICNAS. 2006; Roy. 1999).
Gross dissection and examination of the tissue typically take place in pathology or other medical
laboratories after the specimen has been in full contact with a formalin solution containing 3.7 percent
formaldehyde for several hours or longer (Xu and Stewart. 2016; NIOSH. 1983). The tissue is placed
into plastic cassettes and the cassettes are immersed in trays of formalin during grossing (Xu and
Stewart. 2016). The cassettes are processed into paraffin blocks, sliced extremely thin, and mounted on a
slide (Xu and Stewart. 2016; Kilburn et al.. 1985; NIOSH. 1982b). The slide goes through a series of
solutions where stains are applied, and the slides are fixed (NIOSH. 1982b). A pathologist examines the
slide via microscopic analysis (Xu and Stewart. 2016; NIOSH. 1982b). One source indicates that
specimens no longer needed are disposed of once a week. The specimen is rinsed with water and the
formaldehyde is washed down the sink (NIOSH. 1982b). Loading tissue cassettes and tissue processing
typically takes 1.5 hours and may occur up to several times a week (NIOSH. 2013).
Formaldehyde can be used in commercial laboratories for microscope slide preparation and is used to
bind proteins in order to make cells or tissues more structurally solid in the short term. For example, an
animal cell may be mobile on a glass slide so a fixative that contains formaldehyde could be applied to
that slide, so the cell is no longer mobile. EPA has determined that these fixative purposes are in scope
because this use is considered non-pesticidal. Use for slide preparation could potentially have a short-
term fixative (non-preservation) purpose if there is not also an intent to preserve the tissue for later
analysis.
In the aerospace industry, formaldehyde is used in laboratories for tissue fixing, freeze drying aerosol
droplets, and lab reagent purposes. This COU also includes activities identified by the U.S. Department
of Defense.
Formaldehyde may also have uses in laboratories as an analytical standard for various applications. The
users of products under this category would be expected to apply these products through general
laboratory use applications.
A.51 Consumer Use - Chemical Substances in Furnishings Treatment/Care
Products - Floor Coverings (Including Stone, Plaster, Cement, Glass and
Ceramic Articles); Foam Seating and Bedding Products; Cleaning and
Furniture Care Products; Furniture and Furnishings; Metal Articles; or
Rubber Articles
This COU is referring to the consumer use of formaldehyde as a chemical substance in furnishings, such
as floor coverings, foam seating and bedding products, as well as furniture and furnishings including
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stone, plaster, cement, glass, ceramic, metal, or rubber articles.
This COU includes several uses of formaldehyde in furniture and furnishings. For example,
formaldehyde-based resins are also found in wood-based articles such as composite wood articles. Wood
panel articles may be used for shelving, furniture, doors, cabinets, and flooring. Formaldehyde based
resins are also present in other wood products such as bamboo and cork flooring.
Formaldehyde resins may also be present in fiberglass insulation and urea-formaldehyde foam insulation
products which are found at local home improvement stores.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.52 Consumer Use - Chemical Substances in Furnishings Treatment/Care
Products - Fabric, Textile, and Leather Products (Clothing)
This COU is referring to the consumer use of formaldehyde as a chemical substance in fabric, textile,
and leather products such as clothing.
Formaldehyde is found in wrinkle-resistant clothing and may also be present in certain clothing fabrics
and synthetic fibers to preserve the color.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.53 Consumer Use - Chemical Substances in Treatment Products - Water
Treatment Products
This COU is referring to the consumer use of formaldehyde as a chemical substance in water treatment
products.
This use was not reported in 2016 or 2020 CDR.
A.54 Consumer Use - Chemical Substances in Treatment/Care Products -
Laundry and Dishwashing Products
This COU is referring to the consumer use of formaldehyde as a chemical substance in laundry and
dishwashing products.
Safety data sheets have, in the past, identified the use of formaldehyde in liquid laundry detergent and
fabric softener, as well as dishwashing liquid. Such products have historically included laundry
detergents, fabric conditioners, and rug and upholstery cleaners that contain formaldehyde. EPA has not
found any current safety data sheets indicating that formaldehyde is still present in consumer uses for
laundry and dishwashing products.
EPA expects that these products are likely to be used in both commercial and consumer applications.
This COU was not reported in the 2016 or 2020 CDR.
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A.55 Consumer Use - Chemical Substances in Construction, Paint, Electrical,
and Metal Products - Adhesives and Sealants; Paint and Coatings
This COU is referring to the consumer use of formaldehyde as a chemical substance in adhesives,
sealants, paints, and coatings.
Formaldehyde is found in certain consumer adhesive and sealant products, including craft glues, wood
glues, caulking and putty, tile grout and sealer, spackle, and other construction adhesives. Formaldehyde
is also used in a variety of household paints and coatings, including lacquers, stains, varnishes, primers,
topcoats, and specialty coatings. Such products can be found at local home improvement stores,
hardware stores, and department stores.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.56 Consumer Use - Chemical Substances in Construction, Paint, Electrical,
and Metal Products - Construction and Building Materials Covering
Large Surface Areas, Including Wood Articles; Construction and
Building Materials Covering Large Surface Areas, Including Paper
Articles; Metal Articles; Stone, Plaster, Cement, Glass and Ceramic
Articles
This COU is referring to the consumer use of formaldehyde as a chemical substance in construction and
building materials including wood articles, paper articles, metal articles, and stone, plaster, cement,
glass, and ceramic articles.
Formaldehyde is in construction-based materials found at local home improvement stores including
building insulation, concrete and cement, glass products, laminates, and other miscellaneous
construction materials such as ceiling tiles, wall coverings, bricklaying, plumbing components, glass
fiber roofing mats, and plastic construction materials.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.57 Consumer Use - Chemical Substances in Electrical Products -
Machinery, Mechanical Appliances, Electrical/Electronic Articles; Other
Machinery, Mechanical Appliances, Electronic/Electronic articles
This COU is referring to the consumer use of formaldehyde as a chemical substance in electrical,
mechanical, and appliance products and articles.
Formaldehyde is found in numerous electrical and electronic products and articles, including in printed
circuit board materials and in appliances, electric controls, telephones, electrical switches, circuit
breakers, and virtually all electronic products such as cell phones, video game consoles, laptop
computers, and calculators. The expected users of products under this category would be consumers who
are living in indoor environments with various electrical and electronic products or articles containing
components made with formaldehyde as part of their construction.
EPA expects that these products are likely to be used in both commercial and consumer applications.
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A.58 Consumer Use - Chemical Substances in Automotive and Fuel Products
- Automotive Articles and Automotive Care Products; Lubricants and
Greases; Fuels and Related Products
This COU is referring to the consumer use of formaldehyde as a chemical substance in automotive
articles and automotive care products, lubricants and greases, and fuel related products.
Formaldehyde and formaldehyde resins are found in a range of automotive products and articles such as,
under-the-hood components, exterior primers and paints, tire-cord adhesives, brake pads and linings,
clutch facings, automatic transmission components, and fuel system components. Formaldehyde is also
found in certain lubricants and greases used for maintenance of a vehicle which are available at local
autobody and mechanical stores.
Formaldehyde is also found in a variety of automotive care products such as waxes, polishes, auto soaps.
Such products may be applied directly onto the car or application equipment (e.g., cloths, buffer pads),
or they may be diluted with water in a bucket before use. For the interior of the vehicle, certain cleaning
materials may be used for vinyl or leather surfaces by wiping the coating onto surfaces and removing
excess coating with cloths.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.59 Consumer Use - Chemical Substances in Agriculture Use Products -
Lawn and Garden Products
This COU is referring to the consumer use of formaldehyde as a chemical substance in non-pesticidal
lawn and garden products.
Urea-formaldehyde is found in controlled-release fertilizers, which release nutrients at a constant rate
over time. End users of controlled-release fertilizers include agricultural, horticultural, landscaping, and
consumer markets. The application depends on a variety of factors including crop type, soil type, and
climate. Common application techniques include surface broadcasting, incorporation into the soil using
attachments to plow, and injection of liquid/gaseous formulations by pumping through cultivator knives.
Dry granulated formaldehyde fertilizers are either broadcast or suspended in water and root-zone
injected or spray-applied.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.60 Consumer Use - Chemical Substances in Packaging, Paper, Plastic,
Hobby Products - Paper Products; Plastic and Rubber Products; Toys,
Playground, and Sporting Equipment
This COU is referring to the consumer use of formaldehyde as a chemical substance in paper products,
plastic and rubber products, toys, and playground and sporting equipment.
Formaldehyde and formaldehyde resins are found in pulp and paper products such as paper, cardboard,
wallpaper, and abrasive paper, such as sandpaper, including certain coatings in paper and cardboard.
Formaldehyde has been identified in carbonless copy paper which may be used in office settings,
educational supply stores, and printing shops.
Formaldehyde can be found in certain plastics and foams used to manufacture toys, playground
equipment, and sporting equipment.
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EPA expects that these products are likely to be used in both commercial and consumer applications.
A.61 Consumer Use - Chemical Substances in Packaging, Paper, Plastic,
Hobby Products - Arts, Crafts, and Hobby Materials
This COU is referring to the consumer use of formaldehyde as a chemical substance in arts, crafts, and
hobby products.
Formaldehyde can be found in colorants, pigments, and dyes in children's arts and craft supplies and
needlework supplies. Paints, coatings, and adhesives are applied manually by brush, roller, or spray onto
the substrate. Following application, the substrate is cured or dried before use.
Formaldehyde can also be found in other hobby materials such as colored paper, cardboard, small
woodworking crafts, hobby glues, and common arts and craft store items.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.62 Consumer Use - Chemical Substances in Packaging, Paper, Plastic,
Hobby Products - Ink, Toner, and Colorant Products; Photographic
Supplies
This COU is referring to the consumer use of formaldehyde as a chemical substance in ink, toner,
colorant products, and photographic supplies.
Phenol-formaldehyde based resins are found in printing ink, toner, and colorants which are commonly
purchased at office supply stores and department stores. Formaldehyde has been identified as a
component in photographic film processing. Formaldehyde is used as a preservative, stabilizer,
replenisher, and hardener in final baths to prevent deterioration of image quality and damage to film
coatings. EPA would expect hobbyists to utilize specialized photographic supplies. Formaldehyde is also
found in printing inks used for newspapers, books, labeling, and packaging.
EPA expects that these products are likely to be used in both commercial and consumer applications.
A.63 Disposal - Disposal
This condition of use refers to the process of disposing generated wasted streams from each of the
conditions of use of formaldehyde that are collected from facilities and households and are unloaded at
and treated or otherwise disposed (e.g., landfilling, waste incineration, underground injection) at third-
party sites. Point source discharges of formaldehyde to surface water are assessed in each discharging
condition of use. Wastes of formaldehyde that are generated during a condition of use and sent to a
third-party site for treatment or final disposition may include wastewater and solid waste. Formaldehyde
may be contained in wastewater discharged to publicly owned treatment works (POTW) or other, non-
public treatment works for treatment. Industrial wastewater containing formaldehyde discharged to a
POTW may be subject to EPA or authorized National Pollution Discharge Elimination System (NPDES)
state pretreatment programs.
Wastes of formaldehyde that are generated during a condition of use and sent to a third-party site for
disposal, including treatment or final disposition (e.g., landfilling, incineration, underground injection)
may include the following:
Wastewater
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Formaldehyde may be contained in wastewater discharged to POTW or other, nonpublic treatment
works for treatment. Industrial wastewater containing formaldehyde discharged to a POTW may be
subject to EPA or authorized NPDES state pretreatment programs.
Solid Wastes
Solid wastes are defined under RCRA as any material that is discarded by being: abandoned; inherently
waste-like; a discarded military munition; or recycled in certain ways (certain instances of the generation
and legitimate reclamation of secondary materials are exempted as solid wastes under RCRA).
Wastes Exempted as Solid Wastes under RCRA
Certain COUs of formaldehyde may generate wastes of formaldehyde that are exempted as solid wastes
under 40 CFR 261.4(a). For example, the generation and legitimate reclamation of hazardous secondary
materials of formaldehyde may be exempt as solid waste.
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Appendix B REGULATORY HISTORY
The chemical substance, formaldehyde, is subject to federal and state laws and regulations in the United States (TableApx B-l and
TableApx B-2). Regulatory actions by other governments, tribes, and international agreements applicable to formaldehyde are listed in
Table Apx B-3. EPA conducted a search of existing domestic and international laws, regulations and assessments pertaining to
formaldehyde. Appendix B contains the compiled information from available federal, state, international and other government sources.
B.l Federal Laws and Regulations
Table Apx B-l. Federal Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
EPA regulations
Toxic Substances Control Act
(TSCA) - Section 6(b)
EPA is directed to identify high-priority chemical
substances for risk evaluation; and conduct risk
evaluations on at least 20 high priority substances no
later than three and one-half years after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act.
Formaldehyde is one of the 20 chemicals EPA designated as a
High-Priority Substance for risk evaluation under TSCA (M
FR 71924. December 30. 2019). Designation of formaldehyde
as high-priority substance constitutes the initiation of the risk
evaluation on the chemical.
Toxic Substances Control Act
(TSCA) - Section 8(a)
The TSCA section 8(a) CDR Rule requires
manufacturers (including importers) to give EPA basic
exposure-related information on the types, quantities and
uses of chemical substances produced domestically and
imported into the United States.
Formaldehyde manufacturing (including importing),
processing and use information is reported under the CDR rule
(85 FR 20122. Anril 9. 2020).
Toxic Substances Control Act
(TSCA) - Section 8(d)
Provides EPA with authority to issue rules requiring
manufacturers (including importers), processors, and
distributors of a chemical substance or mixture to submit
lists and/or copies of ongoing and completed,
unpublished health and safety studies. EPA's Health and
Safety Data Reporting Rule at 40 CFR part 716 generally
requires such submissions for manufacturers (including
importers) and (if specified) processors of substances
covered by part 716.
29 health and safety studies received for Formaldehyde (2021)
(U.S. EPA. ChemView. Accessed February 5. 2024).
Toxic Substances Control Act
(TSCA) - Section 8(e)
Manufacturers (including importers), processors, and
distributors must immediately notify EPA if they obtain
information that supports the conclusion that a chemical
23 risk reports received for formaldehyde, or containing
information related to formaldehyde were received between
1989 and 2011. (U.S. EPA. ChemView. Accessed February 5.
2024). Link to the 8(e) submission crosswalk HERE.
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
substance or mixture presents a substantial risk of injury
to health or the environment.
Toxic Substances Control Act
(TSCA) - Subchapter 6
TSCA Title VI sets formaldehyde emission standards for
composite wood products (i.e., hardwood plywood,
medium density fiberboard, and thin-medium density
fiberboard) and requires that any component parts or
finished goods fabricated with composite wood products
use compliant panels that have met the emission
standards and been tested/certified by an EPA recognized
TSCA Title VI third party certifier. The TSCA Title VI
program also has provisions for labeling, recordkeeping,
import certification, and accreditation/third party
certification oversight and annual reporting on the
regulated composite wood products manufactured by
mills.
TSCA Title VI sets formaldehyde emission standards for
composite wood products (i.e., hardwood plywood, medium
density fiberboard, thin-medium density fiberboard, and
particleboard) and requires third party certification, oversight,
and annual reports to be submitted to EPA annually on all
panel manufacturing under the TSCA Title VI program both
domesticallv and internationallv (40 CFR 770).
Emergency Planning and
Community Right-To-Know
Act (EPCRA) - sections 311-
312
The Community Right-to-Know Requirements of EPCRA
sections 311-312 require facilities to submit Safety Data
Sheets (SDS) to certain authorities for hazardous
chemicals present above certain thresholds if the
Occupational Safety and Health Administration's (OSHA)
Hazard Communication Standard (HCS) requires the
facility to prepare or have the SDS. (The SDS were
formerly known as material safety data sheets (MSDS).)
Facilities must submit the SDS or a list of hazardous
chemicals to their State or Tribal Emergency Response
Commission (SERC or TERC), Local or Tribal
Emergency Planning Committee (LEPC or TEPC), and
local fire department. Facilities must also submit an
annual inventory of these chemicals by March 1 of each
year to their State or Tribal Emergency Response
Commission (SERC or TERC), Local or Tribal
Emergency Planning Committee (LEPC or TEPC), and
local fire department. The information submitted by
facilities must be made available to the public.
Formaldehyde is categorized as an Extremely Hazardous
Substance for purposes of the Community Right-to-Know
Reporting Requirements under 40 CFR part 370. As an
Extremely Hazardous Substance under 40 CFR part 355,
Formaldehyde has a threshold planning quantity (TPQ) of 500
pounds.
EPCRA - Section 313
EPCRA Section 313 established the Toxic Release
Inventory (TRI) and requires annual reporting from
facilities in specific industry sectors that employ 10 or
Formaldehyde is a listed substance subject to reporting
requirements under 40 CFR 372.65 effective as of January 1.
1987.
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
more full-time equivalent employees and that
manufacture, process or otherwise use a TRI-listed
chemical in quantities above threshold levels. A facility
that meets reporting requirements must submit a
reporting form for each chemical for which it triggered
reporting, providing data across a variety of categories,
including activities and uses of the chemical, releases and
other waste management (e.g., quantities recycled,
treated, combusted) and pollution prevention activities
(under section 6607 of the Pollution Prevention Act).
These data include on- and off-site data as well as
multimedia data (i.e., air, land and water).
Federal Insecticide,
Fungicide, and Rodenticide
Act (FIFRA) - Sections 3 and
6
FIFRA governs the sale, distribution and use of
pesticides. Section 3 of FIFRA generally requires that
pesticide products be registered by EPA prior to
distribution or sale. EPA assesses the whole formulation
of pesticide products including active ingredients which
have pesticidal effects and inert ingredients that do not.
EPA keeps lists of inert ingredients that have been
approved for use in pesticide products distinguishing
between those that have been approved for use on food
and those that have not. Pesticide products may only be
registered if, among other things, they do not cause
"unreasonable adverse effects on the environment."
Section 6 of FIFRA provides EPA with the authority to
cancel pesticide registrations if either (1) the pesticide,
labeling, or other material does not comply with FIFRA;
or (2) when used in accordance with widespread and
commonly recognized practice, the pesticide generally
causes unreasonable adverse effects on the environment.
Formaldehyde was registered as an antimicrobial, conventional
chemical on January 25, 1967. In June 2008 EPA published a
reregistration eligibility decision for formaldehyde and
paraformaldehyde (Case 0556; EPA Document 739-R-08-
004). Formaldehyde is currently under registration review, and
the final work plan has been published (EPAHO-OPP-2015-
0739).
Federal Food, Drug, and
Cosmetic Act (FFDCA) -
Section 408
FFDCA governs the allowable residues of pesticides in
food. Section 408 of the FFDCA provides EPA with the
authority to establish tolerances (rules that establish
maximum allowable residue limits), or exemptions from
the requirement of a tolerance, for pesticide residues
(including inert ingredients) on food. Prior to issuing a
tolerance or exemption from tolerance, EPA must
Formaldehyde is no longer exempt from the requirement of a
tolerance (the maximum residue level that can remain on food
or feed commodities under 40 CFR Part 180. Subpart D).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
determine that the tolerance or exemption is "safe."
Section 408(b) of the FFDCA defines "safe" to mean a
reasonable certainty that no harm will result from
aggregate exposures (which includes dietary exposures
from food and drinking water as well as nonoccupational
exposures) to the pesticide. Pesticide tolerances or
exemptions from tolerance that do not meet the FFDCA
safety standard are subject to revocation under FFDCA
section 408(d) or (e). In the absence of a tolerance or an
exemption from tolerance, or where pesticide residues in
food exceed an existing tolerance limit, a food containing
that pesticide residue is considered adulterated and may
not be distributed in interstate commerce.
Clean Air Act (CAA) -
Section 111(b)
Requires EPA to establish new source performance
standards (NSPS) for any category of new or modified
stationary sources that EPA determines causes, or
contributes significantly to, air pollution, which may
reasonably be anticipated to endanger public health or
welfare. The standards are based on the degree of
emission limitation achievable through the application of
the best system of emission reduction (BSER) which
(taking into account the cost of achieving reductions and
environmental impacts and energy requirements) EPA
determines has been adequately demonstrated.
EPA has established NSPS for a number of source categories
that regulate emissions of Formaldehyde to air. (See
https://www.epa.eov/stationarv-sources-air-pollution/new-
source-performance-standards).
Clean Air Act (CAA) -
Section 112(b)
Contains the original list of 189 hazardous air pollutants
(HAPs) that Congress added in 1990. Under 112(c) of the
CAA, EPA must identify and list source categories that
emit listed HAPs and then set emission standards for
those listed source categories under CAA section 112(d).
CAA section 112(b)(3)(A) specifies that any person may
petition the Administrator to modify the list of HAP by
adding or deleting a substance. Since 1990, EPA has both
removed HAPs from and added HAPs to the original list.
Formaldehyde is listed as a HAP (42 U.S.C 7412).
Clean Air Act (CAA) -
Section 112(d)
Directs EPA to establish, by rule, National Emission
Standards for Hazardous Air Pollutants (NESHAPs) for
each category or subcategory of listed major sources and
area sources of HAPs (listed pursuant to Section 112(c)).
EPA has established NESHAPs for a number of source
categories that emit Formaldehyde to air. (See
https://www.epa.20v/stationarv-sources-air-pollution/national-
emission-standards-hazardous-air-pollutants-neshap-8)
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
For major sources, the standards must require the
maximum degree of emission reduction that EPA
determines is achievable by each particular source
category. This is generally referred to as maximum
achievable control technology (MACT). For areas
sources, the standards must require generally achievable
control technology (GACT) though may require MACT.
Section 112(d)(6) requires EPA to review, and revise, as
necessary, (taking into account developments in
practices, processes and control technologies) the
emission standards every 8 years.
Clean Air Act (CAA) -
Section 112(f)
Section 112(f)(2) requires EPA to conduct risk
assessments for each source category subject to section
112(d) NESHAP that require maximum achievable
control technology (MACT) and to determine if
additional standards are needed to reduce remaining
risks; this is required within 8 years of promulgating the
NESHAP.
EPA has promulgated a number of Risk and Technology
Review (RTR) NESHAP and will do so, as required, for the
remaining source categories with NESHAP.
Clean Air Act (CAA) -
Section 183(e)
Section 183(e) requires EPA to list the categories of
consumer and commercial products that account for at
least 80 percent of all volatile organic compound (VOC)
emissions in areas that violate the National Ambient Air
Quality Standards (NAAQS) for ozone and to issue
standards for these categories that require "best available
controls." In lieu of regulations, EPA may issue control
techniques guidelines if the guidelines are determined to
be substantially as effective as regulations.
Formaldehyde is listed under the National Volatile Organic
Compound Emission Standards for Aerosol Coatings (40 CFR
part 59. subpart E). Formaldehyde has a reactivitv factor of
8.97 g03/g VOC.
Clean Water Act (CWA) -
Section 311(b) (2)(A) and
501(a) of the Federal Water
Pollution Control Act.
Requires EPA to develop, promulgate, and revise as may
be appropriate, regulations designating as hazardous
substances, other than oil, which, when discharged
present an imminent and substantial danger to the public
health or welfare, including, but not limited to, fish,
shellfish, wildlife, shorelines, and beaches.
Formaldehyde is a designated hazardous substance in
accordance with Section 311(b) (2)(A) of the Federal Water
Pollution Control Act (40 CFR Section 116.4. see 43 FR 10474
(March 13, 1978)).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
Safe Drinking Water Act
(SDWA) - Section 1412(b)
Every 5 years, EPA must publish a list of contaminants
that: (1) are currently unregulated, (2) are known or
anticipated to occur in public water systems (PWSs) and
(3) may require regulations under SDWA. EPA must also
determine whether to regulate at least five contaminants
from the list every 5 years.
Formaldehyde was identified on both the Third (2009) and
Fourth (2016) Contaminant Candidate Lists (CCL) (74 FR
51850. October 8. 2009) and (81 FR 81099. November 17.
2016).
Resource Conservation and
Recovery Act (RCRA) -
Section 3001
Directs EPA to develop and promulgate criteria for
identifying the characteristics of hazardous waste, and for
listing hazardous waste, taking into account toxicity,
persistence, and degradability in nature, potential for
accumulation in tissue and other related factors such
as flammability, corrosiveness, and other hazardous
characteristics.
Formaldehyde is included on the list of hazardous wastes
pursuant to RCRA 3001. RCRA Hazardous Waste Code: U122
(40 CFR 261.33).
Formaldehyde is also listed as part of various groups of
chemicals in Appendix VII to Part 261 - Basis for Listing
Hazardous Waste as K009, K010, K038, K040, K156, and
K157 (40 CFR Appendix VII to Part 261).
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
AutoAlliance International, Inc. of Flat Rock Michigan and
DamlierChrysler Corporation, Jefferson North Assembly Plant,
Detroit Michigan entries which permit a TCLP extraction
sample not-to-exceed limit of 84.2 mg/L of formaldehyde in
their leachate extract, and a total concentration of
formaldehyde not to exceed 689 mg/kg, and a maximum
allowable groundwater concentration (|ig/L) of 1,380.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
Eastman Chemical Company - Texas Operations which
permits a bottom ash leachable concentration at 347 mg/L.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the Ford
Motor Company Dearborn Assembly Plant which permits a
TCLP extraction sample not to exceed 80 mg/L of
formaldehyde in their leachate extract, a total concentration of
formaldehyde not to exceed 700 mg/kg, and a total
concentration of formaldehyde not to exceed 689 mg/kg, and a
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
maximum allowable groundwater concentration (j^ig/L) of
1,400.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the Ford
Motor Company, Kansas City Assembly Plant which permits a
TCLP extraction sample not to exceed 343 mg/L of
formaldehyde in their leachate extract and a total concentration
of formaldehyde not to exceed 6880 mg/kg.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the Ford
Motor Company, Michigan Truck Plant and Wayne Integrated
Stamping and Assembly Plant which permits a TCLP
extraction sample not to exceed 84.2 mg/L of formaldehyde in
their leachate extract, a total concentration of formaldehyde
not to exceed 689 mg/kg, and a maximum allowable
groundwater concentration (j^ig/L) of 1,380.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the Ford
Motor Company, Wixom Assembly Plant which permits a
TCLP extraction sample not to exceed 84.2 mg/L of
formaldehyde in their leachate extract and a total concentration
of formaldehyde not to exceed 689 mg/kg.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
General Motors Corporation Assembly Plant which permits a
TCLP extraction sample not to exceed 84 mg/L of
formaldehyde in their leachate extract, a total concentration of
formaldehyde not to exceed 700 mg/kg, and a maximum
allowable groundwater concentration (|ig/L) of 1,390.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
General Motors Corporation, Flint Truck and Hamtramck
facilities which permit TCLP extraction samples not to exceed
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
63 mg/L of formaldehyde in their leachate extract and total
concentrations of formaldehyde not to exceed 535 mg/kg.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
General Motors Corporation Janesville Truck Assembly Plant
which permits a TCLP extraction sample not to exceed 43
mg/L of formaldehyde in their leachate extract, a total
concentration of formaldehyde not to exceed 540 mg/kg, and a
maximum allowable groundwater concentration (mg/L) of
0.950.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
General Motors Corporation Lansing Car Assembly - Body
Plant which permits a TCLP extraction sample not to exceed
672 mg/L of formaldehyde in their leachate extract and a total
concentration of formaldehyde not to exceed 2100 mg/kg.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
General Motors Corporation Pontiac East - Body Plant which
permits a TCLP extraction sample not to exceed 63 mg/L of
formaldehyde in their leachate extract and a total concentration
of formaldehyde not to exceed 535 mg/kg.
Formaldehyde is also listed as part of Appendix IX to Part 261
- Wastes Excluded from Non-Specific Sources under the
Trigen/Cinergy-USFOS of Lansing LLC at General Motors
Corporation, Lansing Grand River which permits a TCLP
extraction sample not to exceed 84.2 mg/L of formaldehyde in
their leachate extract and a total concentration of formaldehyde
not to exceed 689 mg/kg.
Comprehensive
Environmental
Authorizes EPA to promulgate regulations designating as
hazardous substances, in addition to those referred to in
section 101(14) of CERCLA, those elements,
Formaldehyde is a hazardous substance under CERCLA.
Releases of formaldehyde in excess of 100 pounds must be
reported (40 CFR 302.4).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
Response, Compensation and
Liability Act (CERCLA) -
Sections 102(a) and 103
compounds, mixtures, solutions, and substances which,
when released into the environment, may present
substantial danger to the public health or welfare or the
environment.
EPA must also promulgate regulations establishing the
quantity of any hazardous substance the release of which
must be reported under Section 103.
Section 103 requires persons in charge of vessels or
facilities to report to the National Response Center if
they have knowledge of a release of a hazardous
substance above the reportable quantity threshold.
CERCLA Hazardous substances listed under 40 CFR
Table 302.4 are subject to EPCRA Section 304
notification requirements.
Superfund Amendments and
Reauthorization Act (SARA)
Amendments made several important changes to
CERCLA, for example: requires the Agency to revise the
hazardous ranking system and update the National
Priorities List of hazardous waste sites, increases state
and citizen involvement in the Superfund program and
provides new enforcement authorities and settlement
tools.
Formaldehyde is listed as number 224 scoring 605 points on
SARA, an amendment to CERCLA and the CERCLA Priority
List of Hazardous Substances. This list includes substances
most commonly found at facilities on the CERCLA National
Priorities List (NPL) that have been deemed to pose the
greatest threat to public health.
Other federal regulations
Federal Food, Drug, and
Cosmetic Act (FFDCA)
Provides the FDA with authority to oversee the safety
of food, drugs and cosmetics, except residues of
pesticides in food are regulated by EPA under FFDCA
section 408 (discussed above where applicable).
The FDA regulates formaldehyde as an indirect food
additive under its food additive and GRAS regulations (21
CFR 175.105. 175.210. 175.300. 176.170. 176.180.
176.200. 176.210. 177.1460. 177.1900. and 177.2480).
Formaldehyde is also listed as an adhesive used in food
packaging at 21 CFR 175.105.
Formaldehyde is regulated by FDA as a food additive used
in the manufacture of animal feeds in accordance with 21
CFR 573.460.
Formalin (an aqueous solution containing approximately
37% by weight of formaldehyde gas, U.S.P.) is regulated by
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
FDA as a new animal drug when used to control external
parasites on hatcherv fish and their cees. 21 CFR 529.1004.
Formaldehyde is also listed as an "Inactive Ingredient for
approved Drug Products" by FDA with an established limit
of 0.2% Weight/Weight (WAV) on the amount of
formaldehyde that can be present a solution, and 0.27%
WAV on the amount of formaldehyde that can be present in
an emulsion or cream (FDA Inactive Ingredient Database,
Accessed April 10, 2019).
Federal Hazardous Substance
Act (FHSA)
Requires precautionary labeling on the immediate
container of hazardous household products and allows
the Consumer Product Safety Commission (CPSC) to
ban certain products that are so dangerous or the nature
of the hazard is such that labeling is not adequate to
protect consumers.
Under the Federal Hazardous Substance Act, Section
1500.83(a)(31), formaldehyde and products containing 1% or
more formaldehyde are listed as "strong sensitizer" substances
bv CPSC (16 CFR 1500.13).
Occupational Safety and
Health Act (OSH Act)
Requires employers to provide their workers with a place
of employment free from recognized hazards to safety
and health, such as exposure to toxic chemicals,
excessive noise levels, mechanical dangers, heat or cold
stress or unsanitary conditions (29 U.S.C section 651 et
seq.).
Under the Act, OSHA can issue occupational safety and
health standards including such provisions as Permissible
Exposure Limits (PELs), exposure monitoring,
engineering and administrative control measures, and
respiratory protection.
OSHA issued occupational safety and health standards for
formaldehyde that included a PEL of 0.75 ppm as an 8-hour
TWA, a 15-minute STEL of 2 ppm, exposure monitoring,
control measures and respiratory protection (29 CFR
1910.1048). OSHA has separate sections of the CFR for
formaldehyde standards for shipyard (29 CFR 1915.1048) and
construction (29 CFR 1926.1148) employment; however, those
sections reference the general formaldehyde requirements at 29
CFR 1910.1048. 10 CFR 851.23. Worker Safetv and Health
Program, requires the use of the 2016 American Conference of
Governmental Industrial Hygienists (ACGIH) threshold limit
values (TLVs) if they are more protective than the OSHA PEL.
Federal Hazardous Materials
Transportation Act (HMTA)
Section 5103 of the Act directs the Secretary of
Transportation to:
• Designate material (including an explosive,
radioactive material, infectious substance, flammable
or combustible liquid, solid or gas, toxic, oxidizing or
corrosive material, and compressed gas) as hazardous
when the Secretary determines that transporting the
material in commerce may pose an unreasonable risk
to health and safety or property.
The Department of Transportation (DOT) has designated
Formaldehyde solutions as a hazardous material, and there are
special requirements for marking, labeling and transporting it
(49 CFR 172.101(a)).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
• Issue regulations for the safe transportation, including
security, of hazardous material in intrastate, interstate
and foreign commerce.
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B.2 State Laws and Regulations
Table Apx B-2. State Laws and Regulations
State Actions
Description of Action
State Air Regulations
Allowable Ambient Levels (AAL) of Formaldehyde in New Hampshire (Env-A 1400: Regulated Toxic Air Pollutants) is
1.3 (|ig/m3) for a 24-hour AAL, 0.88 (fig/nr1) for an annual AAL, 0.015 lbs/day for a 24-hour de-minimis, and 5.6
lbs/year for an annual de-minimis.
Acceptable Ambient Levels (AAL) of Formaldehyde in Rhode Island is 50 (|ig/m3) for a 1-hour AAL, 40 (jig/nr1) for a
24-hour AAL, and 0.08 lbs/year for an annual (Air Pollution Regulation No. 22). As well, the requirement for registration
has a threshold of 9 lbs/year as a minimum quantity for air emissions of formaldehyde; any exceedance of this minimum
would trigger a reporting reauirement the following vear (Air Pollution Regulation No. 22.4.2(c)).
State Drinking Water
Standards and Guidelines
Formaldehyde is listed in the groundwater: residential and nonresidential part 201 generic cleanup criteria and screening
levels in Michigan with the following levels: residential drinking water criteria of 1,300 ppm, nonresidential drinking
water criteria of 3,800 ppm, groundwater surface water interface criteria of 120 ppm, residential groundwater
volatilization to indoor air inhalation criteria of 63,000 ppm, nonresidential groundwater volatilization to indoor air
inhalation criteria of 360.000 ppm. and a water solubilitv of 550.000.000 ppm (Mich. Admin. Code r.299.44 and
r.299.49. 2017).
State PELs
California (PEL of 0.75 ppm and a STEL of 2 (Cal Code Regs. Title 8. § 5155 and Cal Code Regs. Title 8. § 5217)
Hawaii PEL: 0.75 ppm and a STEL of 2 for 15 minutes (Hawaii Administrative Rules Section 12-60-50 which refer to 29
CFR § 1910.1048 as a proxy for formaldehyde).
State Right-to-Know
Acts
Formaldehyde is found in the following State Right to-Know Acts: Massachusetts (105 Code Mass. Regs. § 670.000
Appendix A). New Jersey (8:59 N.J. Admin. Code § 9.1) and Pennsylvania (P.L. 734. No. 159 and 34 Pa. Code § 323).
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's products containing Formaldehyde, including
Maine (38 MRSA Chapter 16-D). Minnesota (Toxic Free Kids Act Minn. Stat. 116.9401 to 116.9407). Oregon (Toxic-
Free Kids Act. Senate Bill 478. 2015). Vermont (18 V.S.A § 1776) and Washington State (Wash. Admin. Code 173-334-
130).
Volatile Organic
Compound (VOC)
Regulations for
Consumer Products
Many states regulate Formaldehyde as a VOC. These regulations may set VOC limits for consumer products and/or ban
the sale of certain consumer products as an ingredient and/or impurity. Regulated products vary from state to state, and
could include aerosol coating products and antiperspirant and deodorant (among other products). Aerosol Coating
Product in California (Title 17. California Code of Regulations. Division 3. Chapter 1. Subchapter 8.5. Article 3 and 17
CCR 93120). Antiperspirant and Deodorant in Delaware (Adm. Code Title 7. 1141). Antiperspirant and Deodorant in
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State Actions
Description of Action
Illinois (35 Adm Code 223). Antiperspirant and Deodorant in New Hampshire (Env-A 4100) all have VOC regulations or
limits for consumer products. Some of these states also require emissions reporting.
Airborne Toxic Control
Measure (ATCM)
California regulates Formaldehyde emissions for Composite Wood Products (Title 17. California Code of Regulations.
Division 3. Chapter 1. Subchapter 7.5. Section 93120)
Other
California listed formaldehyde on Proposition 65 in 1988 due to cancer. (Cal Code Regs. Title 27. § 27001).
Formaldehyde is listed as a Candidate Chemical under California's Safer Consumer Products Program (Health and Safety
Code § 25252 and 25253). California issued a Health Hazard Alert for formaldehyde (Hazard Evaluation System and
Information Service. 2016).
Massachusetts designated formaldehyde as a Higher Hazard Substance requiring reporting starting in 2012 (301 CMR
41.00).
B.3 International Laws and Regulations
Table Apx B-3. Regulatory Actions by Other Governments and Tribes
Country/
Organization
Requirements and Restrictions
Canada
Formaldehyde is on the Canadian List of Toxic Substances (CEPA. 1999 Schedule 1). A Priority Substances List (PSL)
Assessment determined that formaldehyde is primarily used in the production of resins and fertilizers and enters the Canadian
environment from direct human sources such as automotive and other fuel combustion and industrial on-site uses. Secondary
formation occurs by the oxidation of natural and anthropogenic organic compounds present in air. The PSL Assessment report
for formaldehyde determined that formaldehyde contributes to photochemical formation of ground-level ozone; and therefore,
continued and improving monitoring at sites likely to release formaldehyde is desirable; especially those sites with industrial
uses for resins and for fertilizers as well as releases from pulp and paper mills. The PSL assessment also recommended
continued investigation into options to reduce indoor air exposure to formaldehyde (Environment Canada Database. Accessed
February 23, 2024.)
Other regulations include:
• Canada's National Pollutant Release Inventory (NPRI).
• Off Road Compression-Ignition Engine Emission Regulations (SOR/2005-32).
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Country/
Organization
Requirements and Restrictions
• CCPA and Governments of Canada, Ontario, and Alberta Memorandum of Understanding for Environmental Protection
Through Action Under CCPA Responsible Care (MOU, August 14, 2013).
• Environmental Emergency Regulations (SOR/2003-307).
• On-Road Vehicle and Engine Emission Regulations (SOR/2003-2).
• Off-Road Small Spark-Ignition Engine Emission Regulations (SOR/2003-355).
• Formaldehyde Emissions from Composite Wood Products Regulations (SOR/2021-148)
European Union
Formaldehyde is listed on the European Chemicals Agency (ECHA) Inventory (EC Number 200-001-8) and the European
Union (EU): Classification. Labelling and Packaaina (CLP) Harmonized Classification (index number 605-001-00- 5).
Formaldehyde was evaluated under the 2013 Community rolling action plan (CoRAP) under regulation (EC) No 1907/2006 -
REACH (Reaistration. Evaluation. Authorisation and Restriction of Chemicals (European Chemicals Aaencv (ECHA)
database. Accessed February 5. 2024).
On July 2023, the European Union revised the restrictions under REACH with respect to formaldehyde and formaldehyde
releasers, and established limits for formaldehyde releases of 0.062 mg/m3 for furniture and wood-based articles and of 0.080
mg/m3 for articles other than furniture and wood-based articles. In addition, the regulations established a maximum
concentration of formaldehyde in the interior of in road vehicles of 0.062 ma/m3. (https://eur-lex.europa.eu/leaal-
content/EN/TXT/?uri=CELEX%3A32023R1464&aid=1690878840638)
Australia
Formaldehyde was assessed under a Priority Existing Chemical designation (designated March 5, 2002) in response to
occupational and public health concerns. The main industrial use of formaldehyde is for the manufacture of formaldehyde-
based resins, which are widely used in a variety of industries, predominantly the wood industry. Formaldehyde is also used
directly or in formulations in a number of industries including medicine-related industries (such as forensic/hospital mortuaries
and pathology laboratories), embalming in funeral homes, film processing, textile treatments, leather tanning, and a wide range
of personal care and consumer products. The concentrations of formaldehyde in these products range from 40%, such as in
embalmina and film processina solutions, to < 0.2%. such as in the maioritv of cosmetics and consumer products (NICNAS.
2006. Priority Existina Chemical Assessment Report No. 28 for Formaldehyde. Accessed February 5. 2024).
Japan
Formaldehyde is regulated in Japan under the following legislation:
• Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Chemical Substances Control
Law; CSCL)
• Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of
Improvements to the Management Thereof (Pollutant Release and Transfer Registers & Safety Data Sheet Law (PRTR-
SDS Law))
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Country/
Organization
Requirements and Restrictions
• Industrial Safety and Health Act (ISHA)
• Air Pollution Control Law
• Water Pollution Control Law
• Soil Contamination Countermeasures Act
• Poisonous and Deleterious Substances Control Act
• Act on the Control of Household Products Containing Harmful Substances
• Food Sanitation Act
• Fire Service Act
(National Institute of Technoloav and Evaluation INITEI Chemical Risk Information Platform ICHIRPI. Accessed February 5.
2024).
Basel Convention
B3010 (urea, phenol, and melamine formaldehyde resins) are listed as a category of waste under the Basel Convention.
Although the United States is not currently a party to the Basel Convention, this treaty still affects U.S. importers and exporters.
OECD Control of
Transboundary
Movements of
Wastes Destined
for Recovery
Operations
B3010 (urea, phenol, and melamine formaldehyde resins) are listed as a category of waste subject to The Amber Control
Procedure under Council Decision C (2001) 107/Final.
World Health
Organization
(WHO)
WHO has not established a tolerable daily intake for formaldehyde; however, did note that the average daily intake of
formaldehyde is 0.02 mg/day for outdoor air; 0.05-2 mg/day for indoor conventional buildings, <1-10 mg/day for buildings
without sources of formaldehyde, 0.2-0.8 mg/day for workplaces without occupational use of formaldehyde, 4 mg/day for work
places using formaldehyde, and 0-1 mg/day for environmental tobacco smoke (smoking 20 cigarettes a day corresponds with an
intake of 1 mg/day of formaldehyde). The average daily intake of formaldehyde in drinking water is generally 0.2 mg/day and
the quantity of formaldehyde generally ingested in food (contingent on the meal composition) may range from 1.5 to 14
ma/dav. (Environmental Health Criteria (EHC) Monoaraph 89. 1989).
Australia, Austria,
Belgium, Canada,
Denmark,
European Union,
Finland, France,
Germany,
Occupational exposure limits for Formaldehyde (GESTIS International limit values for chemical agents (Occupational exposure
limits. OELs) database. Accessed February 5. 2024).
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Country/
Organization
Requirements and Restrictions
Hungary, Ireland,
Israel, Italy, Japan,
Latvia, New
Zealand, Norway,
People's Republic
of China, Poland,
Romania,
Singapore, South
Africa, South
Korea, Spain,
Sweden,
Switzerland, The
Netherlands,
United Kingdom
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