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PUBLIC RELEASE - DO NOT CITE OR QUOTE
Version - March 2024
EPA Document #EPA-740-D-24-004
March 2024
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Conditions of Use of the Draft Risk Evaluation for Formaldehyde
CASRN 50-00-0
O
A
H H
March 2024
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TABLE OF CONTENTS
1 INTRODUCTION 3
2 RISK EVALUATION SCOPE 3
2.1 Conditions of Use Included in the Draft Risk Evaluation 3
2.1.1 Additions and Name Changes to Conditions of Use Based on Updated 2020 CDR Reported
Data 9
2.2 Activities Determined Not to Be Conditions of Use 12
2.2.1 Industries Affected by Activities Determined Not to Be Conditions of Use 14
2.2.2 Biogenic Sources of Formaldehyde Not Considered as Conditions of Use 15
2.3 Certain Combustion Sources and Secondary Formation of Formaldehyde 15
2.4 Additions to the Scope Pertaining to Exposure Pathways and Risks Addressed by Other EPA-
Administered Statutes 15
2.5 Clarification Regarding Consideration of Formalin and Paraformaldehyde in the Draft Risk
Evaluation 17
Appendix A Regulatory History 18
A,1 Federal Laws and Regulations 18
A.2 State Laws and Regulations 28
A.3 International Laws and Regulations 29
LIST OF TABLES
Table 2-1. Conditions of Use Included in the Draft Risk Evaluation for Formaldehyde 4
Table 2-2. Additions and Name Changes to Categories and Subcategories of Conditions of Use Based on
Updated Reporting in the 2020 CDR 10
Table 2-3. Subcategories Removed from the Risk Evaluation 12
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 18
Table_Apx A-2. State Laws and Regulations 28
Table_Apx A-3. Regulatory Actions by Other Governments and Tribes 29
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1 INTRODUCTION
This document provides an overview of the conditions of use (COUs) considered for the draft
formaldehyde risk evaluation, pursuant to the Toxic Substances Control Act (TSCA) section 3(4)
definition of "conditions of use" and TSCA section 3(2) definition of "chemical substance." EPA does
not intend to 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) in the draft formaldehyde risk evaluation. However, EPA
did consider potential background 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 CASRN 50-00-0 {U.S. EPA, 2020, 10617344} (2020 Final Scope).
2 RISK EVALUATION SCOPE
The TSCA draft risk evaluation of formaldehyde comprises several human health and environmental
assessment modules and two risk assessment documents—the environmental risk assessment and the
human health risk assessment. A basic diagram showing the layout of these modular assessments and
their relationships 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). These
modules are shown in dark gray.
Figure 2-1. Risk Evaluation Document Summary Map
2.1 Conditions of Use Included in the Draft Risk Evaluation
The Final Scope for the Risk Evaluation for Formaldehyde CASRN 50-00-0 {U.S. EPA, 2020,
10617344} (2020 Final Scope) identified and described the categories and subcategories of COUs that
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EPA planned to consider in the formaldehyde risk evaluation. TSCA section 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 this draft risk evaluation, EPA has edited the formaldehyde COUs listed in the 2020 Final Scope.
These edits reflect EPA's improved understanding of formaldehyde's COUs based on further outreach,
public comments received, and updated industry code names under the Chemical Data Reporting (CDR)
for 2020. These edits included (1) updated additions based on new reporting in CDR for 2020, (2) name
changes based on new industry codes used in CDR for 2020, and (3) changes based on 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 3(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 2.3 and have been removed from this draft risk
evaluation.
EPA may further refine the description of the formaldehyde COUs included in the risk evaluation when
the Final Risk Evaluation for Formaldehyde is published based upon peer review and public comment.
Table 2-1 presents the revised COUs that were included and evaluated in this Draft Risk Evaluation for
Formaldehyde.
Table 2-1. Conditions of Use Inclut
ed in the Draft Risk Evaluation for Formaldehyde
Life Cycle
Stage"
Category''
Subcategory'
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)
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Life Cycle
Stage"
Category''
Subcategory'
Reference(s)
Processing
Reactant
Functional fluid in: Oil and gas drilling,
extraction, and support activities
U.S. EPA (2019a)
Processing
Reactant
Processing aids, specific to petroleum
production in all other 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-OPPI-
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-OPPI-2018-
0438-0006)
Processing
Incorporation into an
article
Additive in rubber product manufacturing
USTMA (EPA-HO-OPPT-
2018-0438-0026); USTMA
(EPA-HO-OI .8-
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-OPPI2018-
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
-OPPT-2018-
0438-0006); EDF (EPA-
HO-OPPT-2018- 0438-
0'
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Life Cycle
Stage"
Category''
Subcategory'
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: all other 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
all other 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)
Processing
Recycling
Recycling
U.S. EPA (2019a)
Distribution in
Commerce
Distribution in
commerce
Distribution in commerce
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Life Cycle
Stage"
Category''
Subcategory'
Reference(s)
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
-OPPI-2018-
0438-
Industrial Use
Non-incorporative
activities
Used in: construction
U.8. 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-OPPI0438-
0050); SAI (EPA-HO-
0 38-0053)
Industrial Use
Chemical substances
in industrial products
Paints and coatings; adhesives and sealants;
lubricants
AIA (EPA-HO-OPPT-
2018-0438-0006)
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.
E Mia)
Commercial
Uses
Chemical substances
in electrical products
Machinery, mechanical appliances,
electrical/electronic articles; Other
machinery, mechanical appliances,
electronic/electronic articles
U.S. EPA (2019a)
Commercial
Uses
Chemical substances
in metal products
Construction and building materials
covering large surface areas, including
metal articles
U.S. EPA (2019a):
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Life Cycle
Stage"
Category''
Subcategory'
Reference(s)
Commercial
uses
Chemical substances
in automotive and
fuel products
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)
Commercial
uses
Chemical substances
in agriculture use
products
Lawn and garden products
U.S. EPA (2019a)
Commercial
Uses
Chemical substances
in outdoor use
products
Explosive materials
U.S. EPA (2019a)
Commercial
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-OPPI-2018-
0438- 0023); ACC (EPA-
HO-OPPI -2018-043 8-
0018)
Commercial
uses
Chemical substances
in packaging, paper,
plastic, hobby
products
Arts, crafts, and hobby materials
U.S. EPA (2019a)
Commercial
Uses
Chemical substances
in packaging, paper,
plastic, hobby
products
Ink, toner, and colorant products;
Photographic supplies
U.S. EPA (2019a);
Commercial
Uses
Chemical substances
in products not
described by other
codes
Laboratory Chemicals
U.S. EPA (2019a)
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.
E Mia)
Consumer Uses
Chemical substances
in furnishing
treatment/care
products
Fabric, textile, and leather products not
covered elsewhere (clothing)
U.S. EPA (2019a); U.S.
E Mia)
Consumer Uses
Chemical substances
in treatment products
Water treatment products
U.S. EPA (2019a)
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)
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Life Cycle
Stage"
Category''
Subcategory'
Reference(s)
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.
E Mia)
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 care products; Lubricants and
greases; Fuels and related products
U.S. EPA (2019a):
USTMA (EPA-HO-OPPI-
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)
a 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.
b 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
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2020 CDR reporting cycle. Therefore, EPA is amending 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. These changes are included in Table 2-1.
Table 2-2. Additions and Name Changes to Categories and Subcategories of Conditions of Use
Based on Updated Reporting in the 2020 CDR
Life Cycle
Stage and
Category
Original Subcategory in the 2020
Final Scope Document
Occurred Change
Revised Subcategory in the 2024
Draft 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;
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
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Life Cycle
Stage and
Category
Original Subcategory in the 2020
Final Scope Document
Occurred Change
Revised Subcategory in the 2024
Draft Risk Evaluation
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
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
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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, such as pesticidal uses regulated under FIFRA. Among other things,
TSCA section 3(2) excludes from the "chemical substance" definition "any pesticide (as defined in
[FIFRA]) when manufactured, processed, or distributed in commerce for use as a pesticide," "tobacco or
any tobacco product," and "any food, food additive, drug, cosmetic, or device (as such terms are defined
in.. .the Federal Food, Drug, and Cosmetic Act (FFDCA). . .) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug, cosmetic, or device" (TSCA section
3(2)(B)(ii), (iii), (vi)).
When developing this draft risk evaluation, EPA concluded that some subcategories of the conditions of
use listed in the final scope are either excluded from the TSCA section 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
has removed these subcategories from the risk evaluation. Table 2-3 summarizes the changes to the
COU subcategory descriptions.
Table 2-3. Subcategories Removed from the Ris
i. Evaluation
Life Cycle
Stage and
Category
Original Subcategory in the 2020
Final Scope Document
Occurred Change
Revised Subcategory in the
2024 Draft 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
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Life Cycle
Stage and
Category
Original Subcategory in the 2020
Final Scope Document
Occurred Change
Revised Subcategory in the
2024 Draft Risk Evaluation
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 for the following reasons:
• 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 section 3(2) definition of "chemical substance" when manufactured, processed, or
distributed in commerce for these uses. (Related: see Commercial Use, Laboratory Chemicals,
"specimenpreservation, medical samples, mortuary science " below.)
• 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
(Bakelite EPA-HQ-QPPT-2018-0438-0134). Depending on the particular facts, 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
section 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. EPA did not identify any formaldehyde-
containing personal care products covered by TSCA.
• Commercial Use, "Food packaging" under the "Food packaging; Paper products; Plastic and
rubber products; Toys, playground, and sporting equipment" 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.
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• 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 section 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.
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. EPA is making additional clarifications and
added details for certain uses outside the scope of TSCA based on public request to explicitly state
which uses will not be covered under the draft 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." However, EPA did
not list specific examples regarding animal feeds or animal drugs. Therefore, EPA is explaining 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
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-
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containing products are therefore excluded from the TSCA section 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 EPA's Office of Pollution
Prevention and Toxics (OPPT) in this draft 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 draft
risk evaluation for formaldehyde, EPA considered these as background exposures that are accounted for
in the ambient air exposure assessment.
2.3 Certain Combustion Sources and Secondary Formation of
Formaldehyde
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.
Because combustion and secondary formation are so abundant and likely result in co-occurring
exposures, this draft risk assessment could not practically or reasonably differentiate secondary
formation, formation from combustion, and direct released of formaldehyde with certainty for this draft
risk evaluation. Secondary formation and combustion are the largest contributor of formaldehyde to
ambient air and indoor air concentrations. A full quantitative evaluation of exposure and risk from
formaldehyde produced during secondary formation and combustion was not practicable and would
impede efforts to conduct a scientifically sound and fit-for-purpose evaluation under TSCA within
statutory timeframes. For purposes of this TSCA draft risk evaluation for formaldehyde, EPA
considered these as background exposures that are accounted for in the outdoor and indoor air exposure
assessment.
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 announced on June 30, 2021, EPA
no longer intends to exclude exposure pathways that are addressed under other EPA-administered
statutes or regulatory programs from the scope of TSCA risk evaluations. As further explained in the
preamble to the proposed rule, Procedures for Chemical Risk Evaluation Under the Toxic Substances
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Control Act (88 FR 74292, 74299-74300, October 30, 2023), EPA has 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, EPA is no longer excluding from the scope of the Draft Risk Evaluation for Formaldehyde
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 no longer intends to exclude exposure pathways that are addressed under other EPA-administered
statutes or regulatory programs from the scope of TSCA risk evaluations, therefore all composite wood
products, including those regulated under TSCA Title VI, are included in the draft formaldehyde risk
evaluation.
EPA has 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 environment. However, the Agency also recognizes that allocating exposures
due to emissions from finished goods in indoor environments might be difficult due to the monitoring
data available for this draft risk evaluation which does not necessarily reflect information after the
implementation of TSCA Title VI.
Regulated composite wood products under TSCA Title VI include hardwood plywood, medium density
fiberboard, and particle board. Some examples of certain wood product containing COUs may include
• 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 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 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 and furniture 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.
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Exposure Pathways from Ambient Air, Drinking Water, Onsite Releases to Land, Disposal and Soil
The draft formaldehyde risk evaluation does not exclude from its scope exposure pathways from
ambient air, drinking water, onsite releases to land, disposal and soil as 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 Draft Human Health Risk Assessment for Formaldehyde
to reflect the exposure 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
draft risk evaluation.
2.5 Clarification Regarding Consideration of Formalin and
Paraformaldehyde in the Draft 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 COUs 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 section 3(2) definition of
"chemical substance" and therefore not included in the Draft Risk Evaluation for Formaldehyde.
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 CASRN 50-0-0.
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Appendix A Regulatory History
The chemical substance, formaldehyde, is subject to federal and state laws and regulations in the United States (TableApx A-l and
TableApx A-2). Regulatory actions by other governments, tribes, and international agreements applicable to formaldehyde are listed in
Table Apx A-3. EPA conducted a search of existing domestic and international laws, regulations and assessments pertaining to
formaldehyde. This appendix contains the compiled information from available federal, state, international, and other government sources.
A,1 Federal Laws and Regulations
Table Apx A-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 (£ . 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. April 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 CFRpart 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.
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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.
Accessed February 5, 2024). Link to the 8(e) submission
crosswalk HERE.
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, and thin-medium density
fiberboard) and requires third party certification,
oversight, and annual reports to be submitted to EPA
annually on all panel manufacturing under the TSCA Title
VI Droaram both domesticallv and internationallv ("40 CFR
770).
Emergency Planning and
Community Right-To-
Know Act (EPCRA) -
Section 313
EPCRA Section 313 - also known as the Toxic Release
Inventory (TRI) - requires annual reporting from facilities
in specific industry sectors that employ 10 or 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).
Formaldehyde is a listed substance subject to reporting
requirements under 40 CFR 372.65 effective as of Januarv
1, 1987.
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
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
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
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.
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 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.
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 I)).
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
EPA has established NSPS for a number of source
categories that regulate emissions of Formaldehyde to air.
(See httDs://www.eDa.gov/stationarv-sources-air-
Dollution/new-source-Derformance-standards).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
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.
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 ( ).
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)).
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.
EPA has established NESHAPs for a number of source
categories that emit Formaldehyde to air. (See
littps ://www .eoa. gov/stationarv-sou rces-air-
Dollution/national-emission-standards-hazardous-air-
Dollutants-neshaD-8)
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
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.
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
needed to reduce remaining risks; this is required within 8
years of promulgating the 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 Dart 59. subpart E). Formaldehvde has a
reactivity factor of 8.97 g 03/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 Sectic . see
43 FR 10474 (March 13. 1978)).
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 Aooendi: Part 261).
Formaldehvde is also listed as part of Appendix IX to Part
26.1. - Wastes Excluded from Non-Specific Sources under
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
the Auto Alliance 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
(Hg/L) of 1,380.
Formaldehyde is also listed as part of Aooendix IX to Part
26.1. - 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 Aooendix IX to Part
26.1. - 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 maximum allowable groundwater
concentration ((.ig/L) of 1,400.
Formaldehyde is also listed as part of Aooendix IX to Part
26.1. - 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 Aooendix IX to Part
26.1. - Wastes Excluded from Non-Specific Sources under
the Ford Motor Company, Michigan Truck Plant and
Wayne Integrated Stamping and Assembly Plant which
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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
(Hg/L) of 1,380.
Formaldehyde is also listed as part of Aooendix IX to Part
26.1. - 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 Aooendix IX to Part
26.1. - 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
(jig/L) of 1,390.
Formaldehyde is also listed as part of Aooendix IX to Part
26.1. - Wastes Excluded from Non-Specific Sources under
the General Motors Corporation, Flint Truck and
Hamtramck facilities which permit TCLP extraction
samples not to exceed 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 Aooendix IX to Part
26.1. - 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
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exceed 540 mg/kg, and a maximum allowable
groundwater concentration (mg/L) of 0.950.
Formaldehvde is also listed as part of Appendix IX to Part
26.1. - 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.
Formaldehvde is also listed as part of Appendix IX to Part
26.1. - 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.
Formaldehvde is also listed as part of Appendix IX to Part
26.1. - 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
Response, Compensation
and Liability Act
(CERCLA) - Sections
102(a) and 103
Authorizes EPA to promulgate regulations designating as
hazardous substances, in addition to those referred to in
section 101(14) of CERCLA, those elements, 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
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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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.
Oilier 1'ederal reuulalions
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 I V (05. ( .'(0. I 300. 176.170. I V 1.80.
I V 200. 176.210. 177.1460. 177.1900. and 177.2480).
Formaldehyde is also listed as an adhesive used in food
packaging at 21
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 FDA as a new animal drug
when used to control external parasites on hatchery fish
and their eaas. 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
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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 ( R 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 TWA,
exposure monitoring, control measures and respiratory
protection (29 CFR 48(c)( IV). OSHA has separate
sections of the CFR for formaldehyde PELs for shipyard
and construction employment; however, those sections
reference the generic formaldehyde PEL at
1910.1048(c)(1). 10 CFR 851.23. Worker Safetv and
Health Program, requires the use of the 2005 (updated in
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.
• Issue regulations for the safe transportation, including
security, of hazardous material in intrastate, interstate
and foreign commerce.
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(e)).
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A.2 State Laws and Regulations
TableApx A-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 trieeer 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 (('..)! l\vie Rees. Title 8, § 5155 and Cal Code Rees. Titl v 1 )
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 8 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. Rees. § 670.000
Aooendix A). New Jersey (8:59 N.J. Admin. Code S 9.1) and Pennsylvania (P.L. 734. T and 34 Pa. Code S 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 Chapt ). Minnesota (Toxic Free Kids Act Minn. Stat. 116.9401 to 116.9407). Oregon (Toxic-
Free Kids Act Senate Bill 478, 2015). Vermont ( x ) 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 composite wood products, aerosol coating products, as well as antiperspirant and deodorant (among other
products). Composite Wood Products (Title ifomia Code of Regulations, Division 3, Chapter 1, Subchapter 7.5,
Section 93120) and Aerosol Coating Product in California (Title Jifomia Code of Regulations, Division 3, Chapter
I I* fibchapter 8.5. Article 3 and 17 CCR 93120). Antiperspirant and Deodorant in Delaware (Adm. Code Title ' INI).
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Antiperspirant and Deodorant in Illinois ("35 A dm Code 223). Antiperspirant and Deodorant in New Hampshire CEnv-A
i) all have VOC regulations or limits for consumer products. Some of these states also require emissions reporting.
Other
California listed formaldehvde 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 formaldehvde ("Hazard Evaluation System and
Information Service. 20.1.6).
Massachusetts designated formaldehvde as a Higher Hazard Substance reauiring reporting starting in 2012 (301 CMR
41.00).
A.3 International Laws and Regulations
Table Apx A-3. Regu
atory Actions by Other Governments and Tribes
Country/
Organization
Requirements and Restrictions
Canada
Formaldehyde is on the Canadian List of Toxic Substances (CEPA. .1.999 Schedule IV 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).
• 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).
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Requirements and Restrictions
• 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. (httDs://eur-lex.euroDa.eu/leaal-
content/EN/TXT/?un=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 embalming and film processing solutions, to < 0.2%, such as in the majority of cosmetics and consumer products
fNICNAS. 2006. Priority Existing 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))
• 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
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Requirements and Restrictions
• Food Sanitation Act
• Fire Service Act
("National Institute of Technology and Evaluation [In nemical Risk Information Platform fCHIRPl. Accessed February
5, 2024).
Basel Convention
B3010 (urea, phenol, and melamine formaldelnde resins) are listed as a cateaorv 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 » t.\Vh 10 ' « uial.
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 14ms/dav. (Environmental Health Criteria (EHC) Monograph 89. 1989).
Australia, Austria,
Belgium, Canada,
Denmark, European
Union, Finland,
France, Germany,
Hungary, Ireland,
Israel, Italy, Japan,
Latvia, New Zealand,
Norway, People's
Republic of China,
Poland, Romania,
Singapore, South
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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Africa, South Korea,
Spain, Sweden,
Switzerland, The
Netherlands, United
Kingdom
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