United States-Canada Regulatory Cooperation Council
U.S. Environmental Protection Agency
Significant New Use Rule (SNUR) Programs and
Environment and Climate Change Canada I Health Canada
Significant New Activity (SNAc) Provisions
An educational primer intended to promote compliance
April 2018
EPA 730-R-17-001
En14-320/2018E-PDF
978-0-660-25901-7
v>EPA Canada
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U.S. Environmental Protection Agency Significant New Use Rule (SNUR) Programs and
Environment and Climate Change Canada / Health Canada Significant New Activity (SNAc) Provisions
This primer provides information and example scenarios meant to serve as an easy-to-follow resource for
understanding Significant New Use Rule (SNUR) and Significant New Activity (SNAc) compliance. The
primary goal of this document is to promote compliance among the regulated community. This
document does not substitute for any SNUR or SNAc provisions, nor is it a rule itself. It does not impose
legally binding requirements on the regulated community or on the U.S. Environmental Protection
Agency, Environment and Climate Change Canada, or Health Canada.
Prepared under contract GS-10F-0048X and contract EP-W-16-017 through EPA's Office of Chemical
Safety and Pollution Prevention / Office of Pollution Prevention and Toxics / Chemical Control Division.
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U.S. Environmental Protection Agency Significant New Use Rule (SNUR) Programs and
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Table of Contents EPA 730-R-17-001 / Enl4-320/2018E-PDF / 978-0-660-25901-7
Acronym Listing v
1. Introduction[[[ 1
1.1 Purpose 1
1.2 Canada-United States Partnership and the Regulatory Cooperation Council (RCC) Process 1
2. U.S. Significant New Use Rules (SNURs): Existing and New Chemicals, under the Toxic Substances
Control A .2
2.1 Overview of SNURs 2
2.2 "Existing" versus "New"' 3
2.3 Substances Excluded from TSCA 3
2.4 The Premanufacture Notice (PMN) Process 3
2.5 New Chemical Determinations 4
2.6 New Chemical SNURs and TSCA Section 5(e) and Section 5(f) Orders 6
2.7 Existing Chemicals 7
2.8 Consumer Products and Articles addressed by SNURs 8
2.8.1 Consumer products 8
2.8.2 Articles 8
2.8.3 Distinction between articles and consumer products 9
2.9 SNUR Provisions 9
2.9.1 Are there notification requirements for protection in the workplace and hazard
communication ? 9
2.9.2 Are there notification requirements for industrial, commercial, and consumer activities? 10
2.9.3 Are there notification requirements for disposal? 10
2.9.4 Are there notification requirements for water releases? 10
2.9.5 Are there recordkeeping requirements? 11
2.9.6 How are imports and exports affected? 13
2.10 Resources to determine if a chemical substance is subject to a SNUR 13
2.10.1 EPA's Substance Registry Services (SRS) 14
2.10.2 ChemView 15
2.11 Significant New Use Notice (SNUN) 16
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3.1 Canadian Authority for SNAcs 18
3.1.1 What are "significant new activities"? 18
3.1.2 What substances are subject to SNAcs? 18
3.1.3 When are SNAc provisions put in place? 20
3.1.4 How are SNAcs published? 21
3.1.5 Available resources to determine if SNAc provisions have been applied to a substance 23
3.2 Obligations for substances subject to SNAc provisions 24
3.2.1 Are there SNAc obligations to notify recipients? 24
3.2.2 What are Significant New Activity Notifications (SNANs)? 24
3.3 Additional SNAc Information 27
3.3.1 Are there requirements for protection in the workplace and hazard communication? 27
3.3.2 Are there requirements for industrial, commercialand consumer activities? 27
3.3.3 Are there disposal requirements? 28
3.3.4 Are there release-to-water requirements? 28
3.3.5 Are there recordkeeping requirements? 28
4. Comparison of the Two Programs 29
4.1 Differences in Regulatory Frameworks for US SNURs and Canada SNACs 29
4.2 Enabling Bilateral Communication 29
5. Resources and Other Supporting Materials 31
5.1 Explanation of Key Terms 32
5.2 ChemView Instructions 33
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Acronym Listing
BLDA
Bilateral Limited Disclosure Agreement
CAS RN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CCPSA
Canada Consumer Product Safety Act
CDX
Central Data exchange (U.S.)
CEPA
Canadian Environmental Protection Act
DSL
Domestic Substances List (Canada)
ECCC
Environment and Climate Change Canada
EPA
U.S. Environmental Protection Agency
HC
Health Canada
HCS
Hazard Communications Standards (U.S.)
MCAN
Microbial Commercial Activity Notice (U.S.)
NAN-C
North American Notification Consultation
NDSL
Non-Domestic Substances List (Canada)
NIOSH
National Institute for Occupational Safety and Health (U.S.)
NOI
Notice of Intent (NOI) (Canada)
NSN
New Substances Notification (Canada)
NSNR
New Substances Notification Regulations (Canada)
OSHA
Occupational Safety and Health Administration (U.S.)
PCB
Polychlorinated biphenyl(s)
PMN
Premanufacture Notice (U.S.)
PNC
Pre-Notice Consultation (Canada and U.S.)
RCC
Regulatory Cooperation Council
SDS
Safety Data Sheet
SNAc
Significant New Activity (Canada)
SNAN
Significant New Activity Notification (Canada)
SNUN
Significant New Use Notice (U.S.)
SNUR
Significant New Use Rule (U.S.)
SRS
Substance Registry Services (U.S.)
TERA
TSCA Experimental Release Application (U.S.)
TSCA
Toxic Substances Control Act (U.S.)
U.S.
United States
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1. Introduction
1.1 Purpose
The purpose of this primer is to compile easy-to-use information for stakeholders potentially
regulated under similar United States (U.S.) and Canadian requirements—Significant New Use
Rules (SNURs) in the U.S. and Significant New Activity (SNAc) provisions in Canada.
Information in this document will assist the regulated community in determining their
compliance obligations, in engaging their supply chains in communication activities to facilitate
compliance with SNUR and SNAc requirements.
1.2 Canada-United States Partnership and the Regulatory Cooperation
Council (RCC) Process
Environment and Climate Change
Canada (ECCC), Health Canada (HC),
and the U.S. Environmental Protection
Agency (EPA) collaborated in the
implementation of a Regulatory
Cooperation Council (RCC) Work Plan
on Chemicals Management that focused
on SNURs and SNAcs.1
EPA and ECCC/HC held two roundtable
meetings in September 2015, to convene
stakeholders throughout the supply chain
and facilitate discussions focused on the
SNUR and SNAc programs. An
overarching issue identified by the
roundtable participants was the need for
improved outreach and education,
ranging from the basics of the
SNUR/SNAc programs to specific requirements for various stakeholders, especially for
potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche
companies in the United States and in Canada. Educational materials are intended to ease
compliance challenges of the various stakeholder groups. Key terms are defined in section 5.
1 ;ttps://www.canada.ca/en/health-canada/services/chemical-substances/chemicals-management-plan/canada-united-
states-regulatory-cooperation-council/workplan-stream-a-new-activitv-provisions.html. accessed April 5, 2017.
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2. U.S. Significant New Use Rules (SNURs): Existing and New Chemicals, under the
Toxic Substances Control Act (TSCA)
2.1 Overview of SNURs
Section 5(a)(2) of the Toxic Substances Control Act (TSCA), as amended by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, authorizes EPA to determine that a use of
a chemical substance is a "significant new use." EPA must make this determination by rule after
considering all relevant factors. These factors include:
• The projected volume of manufacturing (including import) and processing of a chemical
substance;2
• The extent to which a use changes the type or form of exposure of humans or the
environment to a chemical substance;
• The extent to which a use increases the magnitude and duration of exposure of humans or
the environment to a chemical substance; and
• The reasonably anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal of a chemical substance.3
Under TSCA section 5(a)(1), a person desiring to manufacture or process for commercial
purposes the chemical substance or mixtures containing it for a significant new use identified in
the SNUR must notify EPA at least 90 days prior to initiating manufacture or processing for the
significant new use [see 40 CFR §721.5(a)(lYI.
This notification initiates EPA's evaluation of the conditions of use, which means the
circumstances under which a chemical substance is intended, known, or reasonably foreseen to
be manufactured, processed, distributed in commerce, used, or disposed of, associated with the
significant new use within the applicable review period. The person may not manufacture or
process the chemical substance or mixture for the significant new use until EPA has conducted a
review of the notice, made a determination on the notice under section 5(a)(3), and taken such
actions as are required in association with that determination. SNURs can be promulgated for
existing chemicals and new chemicals.
2 Under TSCA Section 3, the definition of the term "manufacture" includes import into the customs territory of the
United States. "Import" is included whenever "manufacture" is used in the context of TSCA in this document.
3 TSCA § 5(a)(2), 15 U.S.C. § 2604(a)(2).
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2.2 "Existing" versus "New"4 5
EPA classifies chemical substances as either "existing" or "new." "Existing" chemical
substances are chemicals that were already in commerce when TSCA was enacted in 1976, and
those that have undergone EPA review since then and have been added to the TSCA Chemical
Substance Inventory.6 Any chemical substance that is not on the TSCA Inventory is classified as
a new chemical. To determine if a substance is a new chemical, it is necessary to consult EPA's
TSCA Inventory, which lists "existing" substances. EPA's Substance Registry Services (SRS)
can be used to determine if a chemical substance is listed on the public TSCA Inventory (see
section 2.10.1). The public version of the Inventory does not contain chemical identities that are
claimed confidential. Someone with a valid commercial need for EPA to verify if a substance is
on the Inventory can submit a Bona Fide Intent to Manufacture or Import Notice ("bona fide
notice") to obtain a written determination from EPA. A chemical is considered new until it is
reviewed under the TSCA New Chemicals Review program and is added to the Inventory.
The TSCA Inventory uses special flags to identify those substances on the Inventory that are the
subject of an EPA rule or order promulgated under TSCA, as well as to indicate types of full or
partial exemption from TSCA reporting requirements. The meanings of the flags are described
on the EPA TSCA Inventory website.7
2.3 Substances Excluded from TSCA
Certain substances are generally excluded from TSCA, including: pesticides (when
manufactured, processed, or distributed in commerce for use as such); foods, food additives,
drugs, and cosmetics (when manufactured, processed, or distributed in commerce for use as
such); tobacco and tobacco products; nuclear material; and munitions, provided that they do not
also have uses subject to TSCA. For the most part, these substances are covered under other
federal laws.
2.4 The Premanufacture Notice (PMN) Process
This discussion of the PMN process is relevant to SNURs, as prior to manufacture or processing
of a new chemical, a notice must be filed with EPA under section 5 of TSCA. A PMN must be
4 https://www.epa.gov/tsca-inventorv. accessed April 7, 2017.
5 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/basic-information-review-
new, accessed September 1, 2016.
6 https://www.epa.gov/tsca-inventorv/how-access-tsca-inventorv. accessed September I, 2016.
7 ibid.
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submitted at least 90 days prior to initiating the activity. Significant New Use Notices (SNUNs)
submitted in response to a SNUR are handled the same way.
Further, there are similar TSCA section 5 notice requirements for the manufacture or processing
of living microorganisms, which can also result in issuance of a SNUR. A Microbial Commercial
Activity Notice (MCAN) is submitted for commercial "new" (intergeneric) microorganisms.8'9
Further information on MCANs and regulation of biotechnology under TSCA can be found in
the EPA Fact Sheet, "Microbial Products of Biotechnology Summary of Regulations under the
Toxic Substances Control Act."10
In general, TSCA section 5 notices require that all reasonably ascertainable information on
chemical identity, production volume, byproducts, use, environmental release, disposal practices,
and human exposure be included in the notice. In addition, EPA requires that the following
information be submitted with the notice: any health and environmental information in the
possession or control of the submitter, parent company or affiliates, and a description of any
other applicable information known to or reasonably ascertainable by the submitter. See 40 CFR
720.45 and 40 CFR 720.50 for specific requirements. Electronic PMN software11 allows
manufacturers of TSCA chemical substances to use the Internet, through EPA's Central Data
eXchange (CDX), to submit TSCA section 5 notices to EPA.
2.5 New Chemical Determinations12
Under TSCA,13 once EPA receives a PMN, MCAN, or significant new use notice (SNUN), the
agency must make one or more of the following determinations:
• "Not likely to present an unreasonable risk" Determinations (See TSCA section
5(a)(3)(C)) - In cases where EPA determines that a new chemical or significant new use
is not likely to present an unreasonable risk of injury to health or the environment,
without consideration of costs or other nonrisk factors, including unreasonable risk to a
potentially exposed or susceptible subpopulation under the conditions of use, EPA will
notify the submitter of its decision under TSCA section 5(a)(3)(C) and the submitter may
commence manufacture of the chemical or manufacture or processing for the significant
8 Those who manufacture, process, and/or import microorganisms for research and development activities are
required to submit a TSCA Experimental Release Application (TERA) in lieu of an MCAN.
9 Please see EPA's webpage for Filing a Biotechnology Submission under TSCA for further guidance:
https://www.epa.gov/regulation-biotechnologv-under-tsca-and-fifra/filing-biotechnology-submission-under-tsca
10 https://www.epa.gov/regulation-biotechnologv-under-tsca-and-fifra/tsca-biotechnology-regulatorv-and-policv-
related, accessed November 4, 2016.
11 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.
accessed September I, 2016.
12 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/regulatorv-actions-under-
tsca#5(f). accessed November 4, 2016.
13 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safetv-21st-
century-act, accessed September 1, 2016.
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new use notwithstanding any remaining portion of the 90-day review period. EPA will
publish its findings in a statement in the Federal Register pursuant to TSCA section 5(g).
This includes cases for which EPA had concerns regarding the conditions of use of a
PMN chemical substance, but such concerns were adequately addressed through
amendment of the PMN made during the review period in conjunction with the issuance
of a SNUR, or issuance of a SNUR without amendment of the PMN.
• "Insufficient Information " Determinations (See TSCA section 5(a)(3)(B)(i)) - In cases
where EPA determines that the available information is insufficient to allow EPA to
make a reasoned evaluation of the health and environmental effects of the new chemical
substance or the significant new use, EPA must issue an order under section 5(e) of
TSCA. A section 5(e) order must prohibit or limit the manufacture, processing,
distribution in commerce, use or disposal to the extent necessary to protect against an
unreasonable risk, and may include testing requirements.
• "Maypresent an unreasonable risk" Determinations (See TSCA section
5(a)(3)(B)(ii)(I)) - In cases where EPA determines that in the absence of sufficient
information, the manufacture, processing, distribution in commerce, use, or disposal of
the chemical may present an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an unreasonable risk to
a potentially exposed or susceptible subpopulation identified as relevant to the EPA
Administrator under the conditions of use, EPA must issue an order under section 5(e) of
TSCA. A section 5(e) order must prohibit or limit the manufacture, processing,
distribution in commerce, use, or disposal to the extent necessary to protect against an
unreasonable risk, and may include testing requirements. Most TSCA section 5(e) orders
issued by EPA are consent orders that are negotiated with the submitter of the PMN,
MCAN or SNUN.
• "Exposure-based" Determinations (See TSCA section 5(a)(3)(B)(ii)(II)) - In cases
where EPA determines that the chemical substance is or will be produced in substantial
quantities and either enters or may reasonably be anticipated to enter the environment in
substantial quantities or there is or may be significant or substantial human exposure to
the substance, EPA must issue an order under section 5(e) of TSCA. A section 5(e) order
must prohibit or limit the manufacture, processing, distribution in commerce, use, or
disposal to the extent necessary to protect against an unreasonable risk, and may include
testing requirements.
• "Presents an unreasonable risk" Determinations (See TSCA section 5(a)(3)(A)) - In
cases where EPA determines that the chemical substance presents an unreasonable risk of
injury to health or the environment, without consideration of costs or other non-risk
factors, including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the EPA Administrator under the conditions of
use, EPA must take action under section 5(f) to protect against the unreasonable risk.
Pursuant to section 5(f), EPA may propose a rule under section 6(a) or may issue an order
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to prohibit or limit the manufacture, processing, or distribution in commerce of the
substance.
2.6 New Chemical SNURs and TSCA Section 5(e) and Section 5(f) Orders
SNURs not associated with Consent Orders. Promulgation of a significant new use rule (SNUR)
can be an effective and efficient way to address reasonably foreseen conditions of use about
which EPA has concerns, as part of the basis for EPA to conclude that the chemical is not likely
to present an unreasonable risk of injury to health and the environment under the conditions of
use under section 5(a)(3)(C). A SNUR requires that any manufacturer or processor - including
the PMN submitter - who intends to undertake the activities subject to the SNUR must submit to
EPA a significant new use notice (SNUN). EPA must either conclude, following review of a
SNUN, that the activities are not likely to present an unreasonable risk under the conditions of
use, or take appropriate action under section 5(e) or 5(f) to protect against any unreasonable risk.
The review would factor in the conditions of use of the chemical specifically associated with the
significant new use and, as appropriate, any other conditions of use relevant to the evaluation of
significant new use under section 5(a)(3). A SNUR enables EPA to focus its technical analysis
on the intended conditions of use of a chemical and defer further analysis of reasonably foreseen
conditions of use until such time as the submitter (or any other entity) actually intends to
undertake them. This is consistent with EPA's long-standing use of SNURs to defer detailed
analysis of activities associated with chemicals until such time as someone indicates the intention
to undertake the activities by submitting a SNUN. See, e.g., 80 Fed. Reg. 2071 (January 15,
2015).
It can be more efficient for EPA to address concerns associated with reasonably foreseen
conditions of use by issuing a SNUR that applies to all parties, including the submitter, rather
than by issuing an order to the submitter addressing activities the submitter does not intend to
undertake, and then taking an additional regulatory action to issue a SNUR.
SNURs following Consent Orders. TSCA section 5(e) and section 5(f) orders are typically
consent orders negotiated with the submitter of the PMN and are only binding on the original
PMN submitter for that substance. Consequently, after issuing a section 5 order, EPA generally
promulgates a SNUR that requires notice to EPA by any manufacturer or processor who wishes
to manufacture or process the chemical in a way other than described in the terms and conditions
contained in the order. TSCA section 5(f)(4) requires EPA to either initiate a SNUR rulemaking
or explain its reasons for not doing so following action under section 5(e) or 5(f). As described
above, a SNUR requires that manufacturers (including importers) and processors notify EPA at
least 90 days before beginning any activity that EPA has designated a "significant new use."
These new use designations are typically those activities prohibited by the section 5 order. The
required notification initiates EPA's evaluation of the conditions of use associated with the
chemical substance within the applicable review period. Manufacturing (including import) or
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processing for the significant new use cannot commence until EPA has conducted a review of
the notice, made an appropriate determination on the notice, and taken such actions as are
required in association with that determination.
In cases where EPA must issue an order under section 5, the consent order typically contains
some or all of the following requirements as conditions:
• Testing for toxicity or environmental fate once a certain production volume or time
period is reached
• Use of worker personal protective equipment
• New Chemical Exposure Limits (NCELs) for worker protection
• Hazard communication language
• Distribution and use restrictions
• Restrictions on releases to water, air and/or land
• Recordkeeping.
2.7 Existing Chemicals
In addition to new chemicals,
SNURs can also be promulgated
for new uses of existing
chemicals. In these cases a SNUR
would require notice to EPA, and
that EPA conduct a review of the
notice, make a determination on
the notice, and take such action as
required in association with that
determination before new uses
could begin or resume. SNURs for
existing chemicals typically occur
in three circumstances: (1) the
chemical has been phased out or
taken off the market for certain
uses or has not been manufactured
for a certain use before, (2) the
chemical is no longer being
manufactured or processed for any
use, or 3) there is a potential or
likely use of a chemical that has
not commenced. This second
Example existing chemical SNUR: trichloroethylene
(81 FR 20535)
EPA's June 2014 Work Plan Chemical Risk Assessment for TCE
identified health risks associated with several trichloroethylene
uses, including the arts and craft spray fixative use, aerosol and
vapor degreasing, and as a spotting agent in dry cleaning facilities.
In 2015, EPA worked with the only U.S. manufacturer of the
trichloroethylene spray fixative product resulting in an agreement
to stop production of the trichloroethylene-containing product and
to reformulate the product with an alternate chemical. The
trichloroethylene spray fixative product was being used by artists,
picture framers, graphic designers, and printers to provide a water
repellent and protective finish.
After the product was taken off the market, EPA then took action
by issuing a SNUR to ensure that no other manufacturers enter the
marketplace for TCE spray fixatives and other consumer uses unless
EPA is notified of the significant new use, makes a determination
and takes such actions as are required in association with the
determination. The significant new use was determined to be the
manufacture or processing for use in a consumer product, with an
exception for ongoing use of trichloroethylene in cleaners and
solvent degreasers, film cleaners, hoof polishes, lubricants, mirror
edge sealants, and pepper spray.
Source: https://www.epa.aov/assessina-and-manaaina-chemicals-
under-tsca/trichloroethvlene-tce. accessed September 1, 2016.
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situation is often referred to as a "dead chemical SNUR." EPA can promulgate an existing
chemical SNUR to ensure that no company will be able to manufacture or process the chemical
for a specific use (circumstance 1) or for any use (circumstance 2) without prior notification to
EPA, and EPA has conducted a review of the notice, made an appropriate determination on the
notice, and taken such actions as are required in association with that determination.14
2.8 Consumer Products and Articles addressed by SNURs
2.8.1 Consumer products
EPA defines consumer product at
40 CFR 721.3 as "a chemical
substance that is directly, or as
part of a mixture, sold or made
available to consumers for their
use in or around a permanent or
temporary household or residence,
in or around a school, or in
recreation" and defines consumer
as "a private individual who uses
a chemical substance or any
product containing the chemical
substance in or around a
permanent or temporary
household or residence, during
recreation, or for any personal use
or enjoyment." The key issue in
this definition is that the chemical
substance be sold or made available to the consumer for her or his own use; for example, the ink
in a pen is made available for the consumer's use but the refrigerant that comes within the
cooling system of a newly purchased car is not made available for the consumer's use.
2.8.2 Articles
Importers and processors of a chemical substance as part of an article are generally exempted
from SNURs pursuant to 40 CFR 721.45(f). but the exemption can be made inapplicable in a
particular SNUR if EPA makes an affirmative finding that there is reasonable potential for
exposure to a chemical substance through an article or category of articles [see TSCA section 5
(a)(5)].
14 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/actions-under-tsca-
section-5%23SNUR#SNURs. accessed September 1, 2016.
Examples of SNURs for Consumer Products
SNUR Citation
Regulatory Text
80 FR 37161
June 30, 2015; 40
CFR 721.10182
. .use in consumer products other than
products used to recharge the motor
vehicle air conditioning systems in
passenger cars and vehicles in which the
original charging of motor vehicle air
conditioning systems with the PMN
substance was done by the motor vehicle
OEM [original equipment
manufacturer]."
79 FR 74639
December 16,
2014;
40 CFR 721.10229
"Any use in a consumer product."
"Any use in a consumer product, except
as a solvent in consumer adhesives, in
brake fluid, as a component of consumer
paint/graffiti removers, and in consumer
paints."
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For SNURs, the Agency relies on the following definition of article in 40 CFR 720.3(c): "a
manufactured item (1) which is formed to a specific shape or design during manufacture, (2)
which has end-use function(s) dependent in whole or in part upon its shape or design during end
use, and (3) which has either no change of chemical composition during its end use or only those
changes of composition which have no commercial purpose separate from that of the article, and
that result from a chemical reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not considered articles regardless of
shape or design."
2.8.3 Distinction between articles and consumer products
Articles can contain chemical substances that are considered consumer products. If an article
makes available a chemical substance for consumer use, then it would be considered an article
that contains a consumer product. An example would be an ink pen. The pen would be
considered an article that contains ink that is made available to the consumer for her or his use.
An example of a difference between an article and a consumer product is automotive brake fluid.
Brake fluid would be considered part of an article when already included within an automobile's
brake lines, but the chemicals in the brake fluid would not be considered to be a consumer
product because the automobile was not purchased for the brake fluid. When the brake fluid is
purchased by a consumer at a car supply store to add to the automobile, that brake fluid would be
considered a consumer product because it has been sold or made available to consumers for their
use.
2.9 SNUR Provisions
There are generally applicable SNUR provisions found in Subpart A of the Code of Federal
Regulations (40 CFR part 721), which include requirements such as recordkeeping. In addition,
the Subpart B provisions are cited for individual SNURs, some of which are described below.
These include workplace protections, hazard communication programs, and restrictions on
disposal and releases to water. As with all SNURs, they are applicable to manufacturers and
processors. The corresponding Canadian topics and provisions are presented in Section 3.3
below.
2.9.1 Are there notification requirements for protection in the workplace and hazard
communication?
New chemical SNURs often use standard language designating certain activities as significant
new uses, set forth in Subpart B of part 721. The sections titled "Protection in the workplace" (40
CFR 721.63) and "Hazard communication program" (40 CFR 721.72) were modeled on
Occupational Safety and Health Administration (OSHA) and National Institute for Occupational
Safety and Health (NIOSH) regulations. When subject to these requirements, a SNUN would be
required before manufacture or processing associated with any use of the SNUR substance
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without establishing personal protective equipment or hazard communication programs
described in those sections, including dermal protective equipment, respirators, a written hazard
communication program, labeling, Safety Data Sheets (SDS), employee information and
training, and certain precautionary statements. EPA has proposed in the Federal Register (see 81
FR 49598; July 28, 2016) changes to the TSCA SNUR regulations to align these regulations with
revisions to the OSHA Hazard Communications Standard (HCS), which are proposed to be
cross-referenced, and with changes to the OSHA Respiratory Protection Standard and the
NIOSH respirator certification requirements pertaining to respiratory protection of workers from
exposure to chemicals.
Section 5(f)(5) of TSCA addresses workplace exposure, instructing the EPA Administrator to
consult with OSHA prior to adopting any prohibition or other restriction relating to a chemical
substance with respect to which EPA has made a determination under 5(a)(3)(A) or (B) to
address workplace exposures.
2.9.2 Are there notification requirements for industrial, commercial, and consumer activities?
The section titled "Industrial, commercial, and consumer activities" can be found at 40 CFR
721.80. Using this provision, a SNUN would be required before manufacture or processing
associated with a wide range of activities (25 are listed in the regulations), including use only in
enclosed processes, a specific use, a specific production volume limit, a specific concentration
limit, limits on the physical form in which a chemical may be used, use in a consumer product,
and specific application method during use (e.g., aerosol). No further detail is provided in the
regulations for the terms "industrial, commercial, and consumer activities," beyond the
definitions provided generally in 40 CFR 721.3. EPA decided that in many instances it was more
practical to simply identify the category of use that is of concern. Evaluation of a specific new
use occurs at the time of SNUN submission.
2.9.3 Are there notification requirements for disposal?
The section titled "Disposal" can be found at 40 CFR 721.85. Using this provision, a SNUN
would be required before manufacture or processing associated with certain methods of disposal,
such as incineration, landfill, or deep well injection.
2.9.4 Are there notificqtion requirements for wqter releqses?
The section titled "Release to water" can be found at 40 CFR 721.90. Using this provision, a
SNUN would be required before manufacture or processing associated with any predictable or
purposeful release of a manufacture, processing, or use stream to surface waters associated with
any use of the SNUR substance. This can be a requirement to notify if the significant new use is
any release, release without certain treatment methods, or release beyond a specified surface
water concentration identified by EPA. The section titled "Computation of estimated surface
water concentrations; instructions" at 40 CFR 721.91 provides guidance to the regulated
community on how to compute estimated surface water concentrations from their facilities.
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2.9.5 Are there recordkeeping requirements?—
The main purpose of the recordkeeping requirements is to know who is making the SNUR
substance, how much are they making, and to whom they are distributing it. It is also important
to have records that show compliance with any provisions that a SNUR may have. The actual
recordkeeping requirements will be SNUR specific. For example, if the significant new use is
solely related to a manufacturing process, regardless of downstream processing and use, then
there would likely not be recordkeeping requirements for downstream processors.
Specific records may be required on the following: 1) documenting the manufacture and
importation volume of the substance and the corresponding dates of manufacture and import; 2)
documenting volumes of the substance purchased in the US by processors of the substance,
names and addresses of suppliers, and corresponding dates of purchase; 3) documenting the
names and addresses of all persons outside the site of manufacture, importation, or processing to
whom the manufacturer, importer, or processor directly sells or transfers the substance, the date
of each sale or transaction, and the quantity of the substance sold or transferred on such date.
Records could also be required to document the establishment and implementation of a program
for the use of any applicable personal protective equipment required; and/or documenting the
establishment and implementation of a hazard communication program; and/or that the chemical
protective clothing, if required, is impervious to the substance.
The actual recordkeeping requirements will vary depending on the conditions of the SNUR. For
example, if water discharge limitations are imposed, then records may be required to document
compliance with those limits. In some cases, for example, if the SNUR only applies to
manufacturers (e.g. manufacture only at a certain average molecular weight), recordkeeping by
downstream processors may not even be needed. The figure on the following page describes the
elements of a SNUR using siloxanes and silicones as an example.
15 40 CFR 721.125. accessed September I, 2016.
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Elements of a SNUR: Siloxanes and Silicones Example (§ 721.10888)
This SNUR is patterned after an accompanying TSCA
section 5(e) consent order signed by EPA with the PMN
submitter.
Section (a)(1) lists the substance to which the SNUR
provisions apply. Substance(s) will generally be listed by
their PMN number and/or CAS number.
Section (a)(2) describes the significant new uses that
apply to the listed substances. This means that any use
other than those described in section (a)(2) requires
notification and Agency review prior to being allowed to
engage in that new use. In this particular example, that
would include not using dermal protection in the
workplace for persons reasonably likely to be exposed,
use other than as a down converter for an optical filter,
etc., or disposal other than by incineration in a
permitted hazardous waste incinerator.
This SNUR is subject to the Protection in the workplace
requirements with references to 40 CFR
721.63(a)(1),(a)(2)(i),(a)(3),(b), and (c). A general
description of workplace and hazard communication
requirements can be found in Section 2.9.1 of this
primer.
This SNUR is subject to disposal requirements. More
general information on disposal requirements can be
found in Section 2.9.3 of this primer.
This SNUR is subject to requirements for industrial,
commercial, and consumer activities. The specific uses
and processes are described here. More general
information on requirements for industrial, commercial,
and consumer activities can be found in Section 2.9.2 of
this primer.
Required recordkeeping requirements for all new
chemical SNURs can be found in: 40 CFR 721.125(a), (b),
and (c). Additional requirements in 721.125 correspond
to the significant new use restrictions described above.
Each manufacturer (including importer) and processor
of the substance shall maintain the records for 5 years
from the date of their creation. More general
information on recordkeeping requirements can be
found in Section 2.9.5 of this primer.
Source: 40 CFR 721.10888
§ 721.10888 Siloxanes and Silicones, 3-1(2-
aminoethyi)amino)propyl Me, di-Me, reaction
products with cadmium zinc selenide sulfide, tauric
acid and oleylamine.
(a) Chemical substance and significant
new uses subject to reporting. (1) The chemical
substance identified as siloxanes and silicones, 3-
[(2-aminoethyl)amino)propyl Me, di-Me, reaction
products with cadmium zinc selenide sulfide, lauric
acid and oleylamine (PMN P-15-59; CAS No.
1623456-05-2) is subject to reporting under this
section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63 (a)(1),
(a)(2)(i), (a)(3), (b), and (c). When determining
which persons are reasonably likely to be exposed
as required for §721.63 (a)(1) engineering control
measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or
administrative control measures (e.g., workplace
policies and procedures) shall be considered and
implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer
activities. Requirements as specified in §
721.80(p)(three months and eighteen months). A
significant new use of the substance is
manufacture, process, or use the chemical
substance other than as a down converter for an
optical filter for light emitting diodes used in
displays, or other than in a liquid formulation.
(iii) Disposal. Requirements as specified in
§ 721.85. It is a significant new use to dispose of the
chemical substance other than by incineration in a
permitted hazardous waste incinerator.
(b) Specific requirements. The provisions
of subpart A of this part apply to this section except
as modified by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125(a), (b), (c),
(d), (e), (i), and (j) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain
notification requirements. The provisions of §
721.185 apply to this section.
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2.9.6 How are imports and exports affected?
As noted above, under TSCA section 3, the definition of the term "manufacture" includes import
into the customs territory of the United States. Imported chemicals may be in bulk or a part of a
mixture or article, as TSCA section 13 makes clear.16 Since imported chemicals are included in
the definition of "manufacture," imported chemicals are generally subject to SNURs and other
TSCA section 5 reporting requirements, though there may be applicable regulatory exceptions.17
For example, someone is not subject to the notification requirements if the person imports or
processes the substance as part of an article (unless otherwise specified in a specific SNUR) or
manufactures or processes the chemical substance solely for export (see 40 CFR 721,45(f and 40
CFR 721.45(g)).
In order for a substance to enter the United States, importers must certify that their imported
chemical substance either is subject to and complies with TSCA ("positive certification") or is
not subject to TSCA ("negative certification").18 If a TSCA chemical substance is subject to a
SNUR, the positive certification would include the fact that the imported substance is in
compliance with the SNUR. Certain chemicals or chemicals that are a part of articles, are exempt
from import certification (unless they are required by a specific rule under TSCA).
Under TSCA section 12(b), any person who exports or intends to export from the United States a
chemical substance or mixture subject to a SNUR must notify EPA of their intent to export, and
EPA will share the information about the substance with the country of import.19 Certain
chemicals, such as mercury, asbestos, hexavalent chromium, and polychlorinated biphenyls
(PCBs), have specific export requirements or limitations.20 Also see 40 CFR 761.97.
2.10 Resources to determine if a chemical substance is subject to a SNUR
EPA has multiple resources to determine whether or not a chemical substance is subject to a
SNUR. These include Substance Registry Services (SRS) and ChemView.
1615 U.S.C. §2612 (2016), http://uscode.house.gov/view.xhtml?rea=ftitle:15%20section:2612%20edition:prelim).
accessed September 1, 2016.
17 EPA. (2016). "TSCA Requirements for Importing Chemicals." Retrieved from https://www.epa.gov/tsca-import-
export-recmirements. accessed July 27, 2016
18 Customs and Border Protection's Import Regulations at 19 CFR 12.118 to 12.127. and 127.28.
19 EPA. (2016). "TSCA Section 6 Import/Export Requirements for Specific Chemicals." Retrieved from
https://www.epa.gov/tsca-import-export-requirements/tsca-section-6-importexport-requirements-specific-chemicals.
accessed July 27, 2016. See 40 CFR 707 subpart D for details.
2015 U.S.C. §2611 (2016), http://uscodc.liou.sc.gov/vicw..\html?hl=falsc&cditioii=prclim&rca=graiiulcid%3AUSC-
prelim-title 15-
section2611&num=0&saved=%7CKHRpdGxlOiEHHNlY3Rpb246MiYwMSBlZG10aW9uQnBvZWxpbSk%3D%7
C%7C%7C0%7Cfalse%7C'prelim. accessed September 1, 2016.
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2.10.1 EPA's Substance Registry Services (SRS)
121
Substance Registry Services (SRS) is EPA's central system for information about substances that
are tracked or regulated by EPA or other sources. It is a resource for basic information about
chemicals, biological organisms, and other substances of interest to EPA and its state and tribal
partners.
SRS makes it possible to identify which EPA data systems, environmental statutes, or other
sources have information about a substance and which synonym is used by that system or statute.
It becomes possible, therefore, to map substance data across EPA programs, regardless of a
given naming convention.
oEPA
United States Environmental Protection Agency
Learn the Issues Science & Technology Laws & Regulations About EPA
Substance Registry Services (SRS)
Search and Retrieve
About
Search & Retrieve
Automated Services References
Espanol I * m&fc I I TiSigViet I sv^O|
Login for EPA & Partners Contact Us Share
Substance Search
Chemical and Substance Resources
Find a Substance
Search by Substance Name
(Enter a Substance Name ex: Chemical Name, Biological Name, etc.)
® Contains O Begins With O Exact Match
Substance Identifier
Please enter a CAS Number, TSN, EPA Identifier, Internal Tracking Number, or Alternate Identifier
Advanced Search
Search bv List
Search bv PMN & Accession
Numbers
Substance Registry Services
• About SRS
• References
The Chemical and Substance Resources search is part
of the Substance Registry Services (SRS), EPA's
authoritative resource for information about chemicals,
biological organisms and other substances tracked or
regulated by EPA.
Search for Services
Keywords:
SRS can be accessed at the following link:
https://iaspub.epa.gov/sor internet/registry/substreg/searchandretrieve/substancesearch/search.do
SRS can be searched for a specific chemical, with the results providing the type of regulation or
other characteristic that affects the status of a chemical. If a chemical is associated with a SNUR,
then the results will be presented as either "TSCA 5(a) Final SNUR" or "TSCA 5(a) Proposed
SNUR." SRS users can also search for complete lists of the "TSCA 5(a) Final SNUR" chemicals
and the "TSCA 5(a) Proposed SNUR" chemicals.
21 https://iaspub.epa.gov/sor internet/registrv/substreg/searchandretrieve/substancesearch/search.do. accessed
September 1, 2016.
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2.10.2 ChemView—
EPA created ChemView to improve chemical safety and provide more streamlined access to
information on chemicals. This database greatly improves access to health and safety data on
chemicals regulated under TSCA. The database currently contains summary and in-depth
information on more than 15,000 chemicals as well as proposed and final SNURs for over 2,800
chemicals. ChemView offers access to thousands of documents including data submitted to EPA,
EPA assessments, and EPA actions such as test data, hazard characterizations, alternatives
assessments, and TSCA regulatory actions. Users can search on a number of parameters, such as
chemical identifier, endpoint, functional use, chemical category, and chemical group. For links to
step-by-step instructions on how to use ChemView to determine if a chemical has a SNUR,
please see Section 5.2.
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U.S. Environmental Protection Agency Significant New Use Rule (SNUR) Programs and
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2.11 Significant New Use Notice (SNUN)23
If EPA determines by rule that a use of a chemical substance is a significant new use, TSCA
requires submission of a SNUN to EPA at least 90 days before a person manufactures or
processes the chemical substance for that use.
If the manufacturer or processor intends to distribute the chemical in commerce for a significant
new use, he or she must submit a SNUN, unless he or she notifies the recipient, in writing, that
the substance has a SNUR, or the manufacturer knows that the recipient already knows this, or
knows that it would be impossible for the recipient to undertake the new use.
While the manufacturer or processor is not legally obligated to enforce the recipient's actions, if
at any time the manufacturer becomes aware of the fact that the recipient is engaging in the new
use without submitting a SNUN, then the manufacturer needs to stop supplying the SNUR
substance to that recipient and the manufacturer may also need to submit a SNUN (exact
requirements are detailed at 40 CFR 721.5). An example of this would be a SNUR that does not
allow for the spray application of the chemical and the recipient of the chemical undertakes spray
application without submitting a SNUN.
The SNUN uses the same form and electronic submission method as the PMN, and initiates
EPA's evaluation of the intended use within the applicable review period. Manufacture and
processing for the significant new use is unable to commence until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and taken such actions as are
required in association with that determination. EPA recommends that SNUN submitters include
information that would permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, processing, use, distribution in commerce, or disposal, as required by the
PMN process (see section 2.4). EPA encourages persons to consult with EPA before submitting a
SNUN. As part of this optional Pre-Notice Consultation (PNC), EPA would discuss specific data
that it believes may be useful in evaluating a significant new use.
2.11.1 When does a person distributing a chemical substance in commerce NOT need to submit
aSNUN?
A person who intends to manufacture or process for commercial purposes a chemical substance
identified within 40 CFR part 721. subpart E, and intends to distribute the substance in
commerce is nonetheless not required to submit a SNUN if that person can document one or
more of the following as to each recipient of the substance from that person:
1. The person has notified the recipient, in writing, of the specific section in subpart E of
Part 721 that identifies the substance and its designated significant new uses.
23 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/filing-significant-new-
use-notice, accessed September I, 2016.
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2. The recipient has knowledge of the specific section in subpart E of Part 721 that
identifies the substance and its designated significant new uses.
3. The recipient cannot undertake any significant new use described in the specific section
in subpart E of Part 721.24
Even if a person is not required to submit a SNUN under the circumstances above, that person
would have to submit a SNUN if that person:
1. Knows at the time of commercial distribution that a recipient intends to engage in a
significant new use without submitting a SNUN (40 CFR 721.5(b)); or
2. At any time thereafter, has knowledge that a recipient is engaging in a significant new use
without submitting a SNUN, subject to limited exception (40 CFR 721.5(d)(1)).
Additionally, a person who processes a chemical substance identified within 40 CFR Part 721.
Subpart E for a significant new use of that substance is not required to submit a SNUN if that
person can document each of the following:
1. The person does not know the specific chemical identity of the chemical substance being
processed, and
2. The person is processing the chemical substance without knowledge that the substance is
identified in 40 CFR Part 721. Subpart E.
24 40 CFR 721.5. accessed September 1, 2016.
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3. Canada's Significant New Activity (SNAc) Provisions25
3.1 Canadian Authority for SNAcs
The Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act.
1999 (CEPA) trigger an obligation for a person (individual or corporation) to provide the
Government of Canada with information about a substance when proposing to use, import, or
manufacture the substance for a significant new activity.26 The government then assesses the
substance for potential risks to human health and/or the environment. The decision to apply the
SNAc provisions for a specific activity in relation to a substance is based on risk. Where
potential changes in exposure to a substance could occur due to the "significant new activity,"
SNAc provisions allow for an assessment to take place prior to the commencement of these
activities. If risks are identified during the assessment, the government could impose
management measures. For further details, sections 80-89 in Part 5 of CEP A27 set out
requirements related to Substances and Activities New to Canada and sections 104 to 115 in Part
6 of CEP A28 set out requirements related to Animate Products of Biotechnology.
Current information on SNAc provisions can be accessed on the ECCC webpage on "The
Significant New Activity Provisions under CEPA."29
3.1.1 What are "significant new activities"?
A "significant new activity" is any activity that results or may result in a higher quantity or
concentration of a substance into the environment or in exposing the environment in a different
manner or circumstance, which could affect environmental or human exposure to the substance.
What constitutes a significant new activity is specific to each substance and is described in the
relevant SNAc publication in the Canada Gazette. It is important to note that the definition of a
"significant new activity" in a SNAc publication for a given substance could include more than
one activity.
3.1.2 What substances are subject to SNAcs?
SNAc provisions can be applied to the full suite of substances regulated under CEPA, and
defined in section 3 of the Act. This includes: chemicals, polymers, biopolymers, biochemicals,
25 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
rcuistr\7simiificaiil-nc\v -activitv-provisioiis.html. accessed November 1, 2017.
26 http://laws-lois.iustice.gc.ca/eng/acts/c-15.31/. accessed April 7, 2017.
27 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
registrv/publications/canadian-environmental-protection-act-1999/part-5.html. accessed November I, 2017.
28 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
registrv/publications/canadian-environmental-protection-act-1999/part-6.html. accessed November I, 2017.
29 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
rcgistr\7sigiiificaiil-nc\v -activitv-provisioiis.html. accessed November 1, 2017.
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nanotechnology and animate objects of biotechnology (living organisms). This includes use of
these substances in industrial and commercial activities and in consumer products.
Section 3 of CEPA also indicates that mixtures, manufactured items, animate matter, and
mixtures that are contained in effluents, emissions or wastes are not considered "substances" for
the purpose of notification requirements under SNAc provisions. However, it should be noted
that individual components of a mixture could be notifiable under the SNAc provisions. Please
refer to the box below for additional information about SNAc provisions and how they apply to
manufactured items and consumer products.
Subsections 81(6) and 106(6) of CEPA30'31 exempt certain uses of substances from notification
under the SNAc provisions such as: using a substance to manufacture or importing a substance
for use in pesticides, fertilizers, and feeds since notification of these uses is required under other
Acts of Parliament, which are listed in Schedules 2 and 4 of CEPA. Additional exclusions are
listed in these subsections and include: transient reaction intermediates that are not isolated;
impurities, contaminants and partially unreacted materials; and incidental reaction products.
For notification and assessment purposes, CEPA distinguishes between "new" substances and
"existing" substances. A list called the Domestic Substances List (DSL) is the sole basis for
determining whether a substance is new for the purposes of the Act and the Regulations. The
DSL is a compilation of all known substances that were in Canadian commerce between 1984
and 1986 or that have been added to the DSL in accordance with CEPA. A substance not listed
on the DSL is considered to be a new substance in Canada. Any person who intends to import or
manufacture a new substance in Canada is required to notify under the New Substances
Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] or the
New Substances Notification Regulations (Organisms) [NSNR (Organisms)]. Following the
assessment under these regulations of a new substance, the SNAc provisions can be applied. For
information on the notification of new substances, refer to ECCC's Evaluating New Substances
webpage.32
Substances listed on the DSL are considered to be existing substances in Canada. Under the
Chemicals Management Plan,33 prioritized existing substances have been subject to risk
assessment and, where warranted following a risk assessment conclusion, subject to SNAc
provisions.
30 https://www.canada.ca/en/environment-climate-change/services/caiiadian-environmental-protection-act-
reuistr\7rclatcd-documciils.html. accessed November I, 2017.
31 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
rcgistr\7rclatcd-documciils.html. accessed November I, 2017.
32 https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-
substaiiccs.html. accessed November 1, 2017
33 https://www.canada.ca/en/health-canada/services/chemical-substances/chemicals-management-plan.html.
accessed November 1, 2017.
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The Non-Domestic
Substances List (NDSL)
is an inventory of
substances that are not
on the DSL, but are
accepted as being in use
internationally. The
NDSL is based on the
US EPA's TSCA
Chemical Substance
Inventory. Substances
that are not on the DSL,
but are listed on the
NDSL, are subject to
the NSNR (Chemicals
and Polymers) and
NSNR (Organisms).
However, they are
subject to fewer
information
requirements.
3.1.3 When are SNAc
provisions put in place?
The decision to use the
SNAc provisions is risk-
based. The SNAc
provisions are
considered for use once
a new or an existing
substance has been
reviewed in accordance
with CEP A, and based
on that review, ECCC
and HC suspect that new activities with a substance may result in new or increased risks to the
environment and/or human health. That conclusion could be based on a number of factors
including: the specific properties of the substance, the function of the substance, or the presence
of the substance in markets in other jurisdictions. In addition, SNAc provisions could be applied
to an existing substance if it is no longer in Canadian commerce, or it is in Canadian commerce
with limited use(s).
SNAcs and Consumer Products/Manufactured Items
Consumer products and manufactured items are treated differently by
SNAcs. The following explains how they are different.
In Canada, where the term "consumer product" is used in a SNAc notice or
order, the term normally references the Canada Consumer Product Safety
Act (CCPSA). Section 2 of the Act defines a consumer product as "a product,
including its components, parts or accessories that may reasonably be
expected to be obtained by an individual to be used for non-commercial
purposes, including for domestic, recreational and sports purposes, and
includes its packaging." This definition includes products used/provided in
commercial settings (e.g., daycare facilities, hotels, etc.) as well as products
that may be purchased by a consumer. The term "consumer product"
normally includes only those products to which the CCPSA applies (Section
4 and Schedule 1 of the CCPSA list products which are excluded from the
definition). If products to which the CCPSA does not apply are of potential
concern, they will be specifically described in the SNAc definition.
A manufactured item is defined under section 3 of CEPA as "...formed into a
specific physical shape or design during manufacture and has, for its final
use, a function or functions dependent in whole or in part on its shape of
design." Where the substance is in a manufactured item, it is generally
excluded from notification under SNAc provisions. However, substances in
fluids and particles contained within a manufactured item may be
notifiable if they are released during normal use in an uncontrolled or
dispersive manner.
Source: Canadian Environmental Protection Act (1999); Guidelines for the
Notification and Testing of New Substances, Chemicals and Polymers (2005) and;
Canada Consumer Product Safety Act
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For further details about when SNAc provisions are applied, refer to the Policy on the Use of
Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 34
3.1.4 How are SNAcs published?
All SNAc notices and orders are published in the Canada Gazette, the official newspaper of the
Canadian Government. There are different procedures and policies in place for publishing SNAc
requirements related to new and existing substances.
The following graphic provides an example of a SNAc publication and identifies the information
contained in each section.
SNAc notices for new substances are published in the Canada Gazette, Part 1 (Notices and
Proposed Regulations) within 90 days after the expiry of the assessment period of the related
new substance notification. Once published, the SNAc notice normally comes into force
immediately. There is no formal comment period prior to or after the publication of the SNAc
notice. A notifier can submit, at any time, information that could have a bearing on the notice.
ECCC and HC will review this information and take appropriate action, if required.
SNAc orders for existing substances are published in the Canada Gazette, in two parts. First in
Part I, a Notice of Intent (NOI), which is considered a draft SNAc order, is published for a 60-
day comment period. This is an opportunity for stakeholders to provide comments to inform the
Canadian Government of any information relating to the existing substance and its current use.
Following the consultation period, a final order applying the SNAc provisions to the substance is
published in Canada Gazette, Part II (Official Regulations). Generally the SNAc order is in force
on the day it is adopted, but occasionally entry into force can occur on a later date.
34 https://www.ee. gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-l
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Elements of a SNAc Publication: Quinoline Example (SOR/2015-73)
SNAcs maybe published in either the Canada Gazette Part I
(Notices - for SN Acs on substances not on the DSL; Notices
oflntent-for S N Acs o n s ubsta nces o n th e DSL) o r Canada
Gazette, Part II (Orders - for SNAcs on DSL substances). In
all cases, information related to the substance identity,
definition of significant new activities, and data
requirements forSNANs is in the same format.
Column 1 is where the substancesa re listed to which the
SNAc provisions apply. Substances will be listed by their CAS
RN and are followed by a flag: the "S"flagindicatesa new
substance newly added to the DSL for which there a re
existing SNAc provisions in force; or th e "S prime" (S')flag
indicates that thesubsta nee wasalready listed onthe DSL
and SNAc provisions have been applied to that existing
substance.
In the example here, the (S')flag is indicated, spedfyingthat
thi s is an existing substanee for wh ich SNAc provisions a re in
force.
Item 1 under Column 2 is where the definition of what
constitutes a "n ew activity" i s described i n the SNAc Notice
or Order. It is important to review this section to see if a
person's intended use of the substance is included in this
definition.
In this example, the significant newactivi tyis defined as
"any activity involving more than 100 kg of the substance in
its isolated form...extracted from naturally occurring sources
or that is manufactured."
Item 2 under Column 2 is where the submission
requirements a re listed for each new use under the SNAc
provis ions. This initial section indicates when the
information must be submitted to the Minister
(government). In this particular case the requirement is
"...180 days before the day on which quantity exceeds 100 kg
in any one calendar year."
Sub-items under Item 2, here listed as (a) through (k),
indicate the information that must be provided to the
Minister within the timefram es specified in Item 2.
Information requirements listed a re often made with
ref e re nee to Sch edules u nd er th e New Substances
Notification Regulations (NSNRj, which have a similar
process and i nformationsubmission requirements. The
regulationsand associated schedulescan be found by
searching the consolidated regulations found on the
Government of Canada website: http://laws-
lois.iustice.gc.ca/eng/regulations/.
Item 3 under Column 2 identifies the length ofti me granted
to the Governmentto reviewand assess the information
provi ded. The assessment period ca n range from 90 to 180
days. In this particular case, the assessment period is 180
days after the day on which the information is received for
that particular submission.
2015-04-22
Canada Gazette Part II,
Vol. 149, No. 8
2. Part 2 of the List is amended by adding the following in
numerical order:
Column 1
Substance
91-22-5 S'
Column 2
Significant new activity for which substance is subject to
subsection 81(3) of the Act
1. Any activity involving in any one calendar year, more than
100 kg of the substance quinoline in its isolated form, namely,
quinoline that is extracted from naturally occurring sources or
that is manufactured.
2. For each proposed significant new activity, the following
information must be provided to the Minister at least 180 days
before the day on which the q uantity of the substa nee exceeds
100 kg in any one calendar year:
(a) a descriptionoftheproposedsignificantnewactivityin
relationto thesubstance;
(b) the anticipated annual quantity of thesubstance to be used;
(c) if known, thethreesitesin Canada where the greatest
quantity of the substance is a nticipated to be used or processed
and the estimated quantitybysite;
(d) the information specified in items 3 to 7 of Schedule 4 to the
New Substa nces Notification Regulations (Chemicals and
Polymers);
(e) the information specified in paragraphs 2(d) to (f)and8(a) to
(g) of Schedule 5 to those Regulations;
(f) the information specified in paragraph 11(b) of Schedule 6 to
those Regulations;
(g) the products and, if known, end-use products that are
a nti cipated to contain the substance, the intended use of those
products and the function of the substance in those products;
(h) a summaryof all otherinformationortestdata in respectof
the substance that are in the possession of the person proposing
the significant new activity, or to which they have access, and
th a t a re re I eva n t to i den tifyi ng ha za rds of th e s ubsta nee to th e
environmentandhumanhealthandthedegreeof
environmental and public exposure to thesubstance;
(i) the identification of every government department or
agency, either outside or with in Canada, to which the person
proposing the significant new activity has provided information
rega rding the substance and, if known, the department or
agency's file number and, ifa ny, the outcome of the assessment
by the department or agency and the risk management actions
in relationto the substa nee imposed by the department or
agency;
(j) the name, civic and postal addresses, telephone number and,
if any, the fax number and email addressof the person proposing
the significantnewactivityand, ifany, the personauthorizedto
acton theirbehalf;and
(k) a certification stating that the information i s accurate and
complete, dated and signed by the person proposingthe
significant newactivi ty, iftheyare resident in Canada or, if not,
by the persona uthorized to acton their behalf.
3. The above information will be assessed within 180 days after
the da yon which it is received by the Minister.
Source: Canada Gazette 12015) Part II: Vol.149. No.8. Page 2. SOR/2015-73
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Environment and Climate Change Canada / Health Canada Significant New Activity (SNAc) Provisions
3.1.5 Available resources to determine ifSNAc provisions have been applied to a substance
The Substances search tool (see example graphic below) can be used to identify substances on
the DSL, substances on the NDSL, as well as substances subject to the SNAc provisions.35
Substances listed on the DSL that are subject to SNAc provisions will be identified using either
"S" or "S"' (S prime) flags. The image below is a screen shot from the Substances search tool on
the Government of Canada website. Users can search for substances using a specific list or group
(DSL, NSNR, SNAc), a substance identifier (Chemical Abstracts Service Registry Number, CAS
RN), or a substance name.
The list of Significant New Activity Publications is a dataset that includes information on all
SNAc orders and notices published under the authority of CEPA and is available on the
Government of Canada's Open Government Portal. Information in the dataset is organized by
substance and includes web addresses to relevant Canada Gazette publications.36 See section 5
Resources and Other Supporting Materials for a list of web-based resources.
Substances listed on the confidential portion of the DSL are published with confidential
accession numbers. SNAc notices published for such substances, as well as those published for
substances not on the DSL where the substance identity is confidential, are referenced by their
confidential accession numbers. Anyone who intends to engage in a significant new activity for a
substance that has been published with a confidential accession number may seek confirmation
from the Substances Management Information Line (see section 5, Resources and Other
Supporting Materials, for contact information).
35 http://pollution-waste.canada.ca/substances-search. accessed June 14, 2017.
36 httD://ooen.Canada.ca/data/en/dataset/bfab5876-77e5-4dbf-8693-3b0bc69428b8?wbdisable=false. accessed
November 1, 2017.
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l+l
Government Gouvernement
of Canada du Canada
Francais
Search Canada.ca
Jobs v
Immigration v
Travel v
Business v
Benefits v
Health v
Taxes v
More services v
Home -» Managing substances in the environment
Substances search
O Find legislative status and program priorities for substances (e.g. chemicals, polymers, and biotechnology organisms).
To see what is currently available, expand the "List or group" pick-list below. Updates are made regularly and new lists and groups will be added ongoing.
Search by list or group to view all substances for the selected list or group.
Search by substance identifier (using one of the following formats) to view all associated lists and groups applicable for the searched substance:
• Chemical Abstract Service Registry Number (CASRN) (e.g.: 50-00-0)
• Environment and Climate Change Canada Confidential Accession Number (e.g.: 10000-1)
• National Pollutant Release Inventory substance identifier (e.g.: na- 12)
• Enzyme Commission Number (e.g.: 1.1.23.21)
• American Type Culture Collection (ATCC) Number. (e.g.: ATCC11866)
Search by substance name: enter any part of a substance name to view a list of substance names containing that part. Select one to view all
associated lists and groups applicable Substance names can vary widely for a substance, so it is recommended to search by identifier where possible.
List or group : - Select a list or group - [v]
View online I Export to Excel
3.2 Obligations for substances subject to SNAc provisions
3.2.1 Are there SNAc obligations to notify recipients?
Sections 86 and 111 of CEPA outline the requirement for mandatory recipient notification for
certain substances subject to SNAc provisions. Under these sections, when transferring
possession or control of a substance that is not listed on the DSL and that is subject to SNAc
provisions (including if the substance is in a mixture), all recipients must be notified of the
obligation to comply with SNAc provisions. This notification enables recipients to determine
their own compliance obligations with respect to the SNAc.
For substances on the DSL subject to a SNAc, it is recommended that this notification also be
carried out to allow recipients to be in a position to determine their own SNAc compliance
obligations. Additionally, notifying recipients ensures open communication within the supply
chain, allowing recipients to inform suppliers/distributors about the SNAc and their use of the
substance.
3.2.2 What are Significant New Activity Notifications (SNANs)?
A Significant New Activity Notification (SNAN) is the information submitted to the government
in compliance with a SN Ac notice or order. The SNAN must contain all of the information
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Environment and Climate Change Canada / Health Canada Significant New Activity (SNAc) Provisions
prescribed in the published notice or order. SNANs must be submitted to the Minister of the
Environment, through Program Development and Engagement Division at ECCC.37
Who needs to submit a SNAN?
If a person's proposed activities with a substance are captured by the significant new activity
definition of a notice or order, and are not subject to any exemptions (see section 3.1.2), that
person is required to submit a SNAN to the government for assessment prior to the
commencement of these activities. The foremost source of information to determine if a SNAc
applies is the SNAc notice or order. Specific timeframes for submission of a SNAN are
mentioned in the specific SNAc publication.
For substances not on the DSL and subject to SNAc provisions, those persons who intend to use
the substance should review the description of the significant new activity in the SNAc notice to
determine whether their proposed activities meet the definition of a significant new activity.
Substances not listed on the DSL also have separate notification requirements under the NSNR
(Chemicals and Polymers) or the NSNR (Organisms) before they are imported or manufactured.
For substances on the DSL and subject to SNAc provisions, manufacturers, importers, and users
of substances who are planning an activity in relation to the substance must determine whether a
SNAN notification is required for their planned activity. Anyone with any questions regarding
whether or not a SNAc order applies to their activities are encouraged to contact the Substances
Management Information Line (see section 5, Resources and Other Supporting Materials).
A company can submit a SNAN on behalf of its customers (known as an "umbrella SNAN"). For
example, in cases where a person receives possession and control of a substance from another
person, the recipient may not be required to submit a SNAN under certain conditions if the
activities were covered by the original SNAN submitted by the supplier. The Substances
Management Advisory Note, Clarification in relation to the submission of Significant New
Activity Notifications in application of the Canadian Environmental Protection Act. 1999.
provides more detail on this subject.38
What is required in a SNAN?
The information required to complete a SNAN is unique to each substance and is described
within the Canada Gazette publication that applies the SNAc provisions to the substance. Many
of the information requirements of SNAcs reference the schedules of the NSNR (Chemicals and
Polymers) and the NSNR (Organisms).39'40
37 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
registry/significant-new-activity-provisions.html. accessed November 1, 2017.
38 http://ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=CC526AE6-l. accessed April 7, 2017.
39 https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-
substaiiccs.html, accessed November 1, 2017.
40 https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-
substaiiccs.html. accessed November 1, 2017.
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Additional guidance on preparing a SNAN can be found in the Guidelines for the Notification
and Testing of New Substances (Chemicals and Polymers) and the Guidelines for the
Notification and Testing of New Substances (Organisms).41'42
Although a specific reporting form is not available for submitting a SNAN, nor is it required,
sections of the New Substances Notification (NSN) Reporting Form may be used as
appropriate.43
A Pre-Notice Consultation (PNC) is available for notifiers who wish to consult with the program
during the planning or preparation of their SNAN to discuss any questions or concerns about the
prescribed information and test plans. To request a PNC or receive more information, contact the
Substances Management Information Line.—
What is a SNAN Assessment?
Once a SNAN is submitted to the government, the Minister of Environment and the Minister of
Health assess the information provided, as well as other available information, to determine
whether the substance could pose a risk to the environment and/or human health, and whether
further risk management measures are required.
Prescribed periods for SNAN assessments are indicated in a SNAc publication. The assessment
period for SNANs can vary, but typically for a new substance SNAN it is 90 days,45 while the
assessment period for organism SNANs is 120 days.46 The time required to complete an
assessment could vary depending on a number of factors, including the information provided in
the SNAN and the complexity of the substance and/or activities being assessed. The Ministers do
have the power to extend the assessment period for a SNAN under subsections 83(4) and 108(4)
of CEP A,47 to a maximum of double the number of days identified in the SNAc notice or order.
The new activity cannot be undertaken until the assessment period of the SNAN has expired.
What is the outcome of a SNAN?
The outcome of the SNAN assessment determines if the substance is considered toxic or not
under Section 64 of CEP A,48 and also informs decisions concerning risk management measures
41 https://www.canada.ca/en/environment-climate-change/services/managing-pollutioii/evaluating-new-
substances/chemicals-polvmers/guidance-documents.html. accessed November 1, 2017.
42 https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-
substances/biotechnology-living-organisms/guidelines.html. accessed November 1, 2017.
43 https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-
substances/chemicals-polvmers/notification-forms/reporting.html. accessed November 1, 2017.
44 https://www.canada.ca/en/health-canada/services/chemical-substances/contact-us.html. accessed November I,
2017.
45 http://laws-lois.iustice.gc.ca/eng/acts/C-15.31/index.html. accessed November 1, 2017.
46 http://laws-lois.iustice.gc.ca/eng/acts/C-15.3 1/inde.vhtml. accessed November 1, 2017.
47 http://laws-lois.iustice.gc.ca/eng/acts/C-15.31/index.html. accessed November 1, 2017.
48 https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-
registrv/publications/canadian-environmental-protection-act-1999/part-5.html. accessed November 1, 2017.
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for the substance if required. There are generally two potential outcomes for a SNAN: toxic or
not toxic.
If the assessment concludes a substance is toxic, risk management measures may be imposed on
the substance to address the new or increased risk to the environment and/or human health. For
new substances this could include conditions or prohibitions under section 84 of CEPA. For
existing and new substances, a range of tools could be implemented, including: voluntary
agreements, addition to the list of toxic substances of CEPA (Schedule 1), regulations,
guidelines, codes of practice, and pollution prevention plans. The SNAcs may also be amended
to exclude those specific activities because they are being risk managed by alternate means, and
to avoid duplicative notification.
When the assessment concludes a substance is not toxic following the assessment, the SNAc
may be amended to exclude those activities that are not of concern and for which notification is
no longer required, or the SNAc could possibly be rescinded, to allow companies to undertake
those activities.
3.3 Additional SNAc Information
This section describes comparable requirements and other information for SNAcs, similar to
those described for US SNURs in section 2.9.
3.3.1 Are there requirements for protection in the workplace and hazard communication?
Health Canada contributes to occupational health and safety (OHS) issues by administering the
Workplace Hazardous Materials Information System in partnership with the federal, provincial
and territorial (FPT) OHS regulatory agencies. Labor legislation falls under the jurisdiction of
Canada's FPT OHS agencies. Consequently, SNAcs do not have requirements for protection in
the workplace and hazard communication.
3.3.2 Are there requirements for industrial, commercial, and consumer activities?
While CEPA and the CCPSA do permit industrial and commercial significant new activities to
be included in SNAc provisions, they are not set out in the same way as is done under TSCA for
significant new uses. These types of activities can be described in a SNAc in three basic ways:
(1) broadly applicable, (2) broadly applicable with exclusions, and (3) targeted. The table below
presents an example of each type. A SNAc definition could be broad and define a significant
new activity as any activity with the substance above a specific threshold. Similarly, a specific
activity regarding the use of a substance in a consumer product could be targeted. It depends on
the substance and for which activities the Canadian government is trying to obtain information
for evaluation. It is incumbent on companies who may be impacted to review the SNAc
publication carefully to determine if their activity could be included in the definition of
significant new activities.
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Examples of Different Types of Significant New Activity Definitions Published in SNAcs
Broadly Applicable
(any use, manufacture or import above a
threshold)
• Order 2013-87-03-01 (CAS RN 116-66-5): "Anv activitv
involving, in any one calendar year, more than 100 kg of
the substance lH-indene, 2,3-dihydro-l, 1,3,3,5-
pentamethyl-4,6-dinitro-."
Canada Gazette, Part II: Vol.147, No.14, Page 1904
Broadly Applicable, with
exclusions
(any use, manufacture or import activity
above a threshold other than x, y, z)
• Order 2013-87-11-01 (CAS RN 88-72-2): "Anv activitv
involving, in any one calendar year, a total of more than
100 kg of the substance Benzene, l-methyl-2-nitro-,
other than an activitv involving its use in the
manufacture of explosives."
Canada Gazette, Part II: Vol.148, No.2, Page 183
Targeted
(specific activity with threshold)
• SNAc Notice No. 18020: ...a significant new activity is the
use of the substance in a quantity greater than 100 kg
per calendar year in any cosmetic or drug as defined in
section 2 of the Food and Drugs Act, or in any natural
health product as defined in subsection 1(1) of the
Natural Health Products Regulations.
Canada Gazette, Part 1: Vol.149, No.23, Page 1096
3.3.3 Are there disposal requirements?
There are no requirements for disposal in SNAc publications. Also, as outlined in section 3.1.2,
section 3 of CEPA lists mixtures as part of effluents, emissions or wastes as not considered
substances for the purposes of notification requirements under SNAc provisions. However,
individual components of mixtures could be notifiable in a SNAc under the definition of the
significant new activity.
3.3.4 Are there release-to-water requirements?
Release-to-water requirements are not managed by SNAc provisions as they are with SNURs.
There are other regulatory risk management tools that the Canadian government uses that have
similar release-to-water requirements (e.g., Ministerial Conditions). Moreover, there are other
federal and provincial laws, such as the federal Fisheries Act, which could apply to these
releases. Persons engaged in activities which include releases to water should follow the
requirements that apply in the jurisdiction where their activities take place.
3.3.5 Are there recordkeeping requirements?
Typically, there are no record-keeping requirements for SNAcs.
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4. Comparison of the Two Programs
4.1 Differences in Regulatory Frameworks for US SNURs and Canada SNACs
As outlined above, both Canada and the U.S. have the authority to require notification and
evaluate risks associated with substances that are new to each country and with substances that
could be used in new ways. In Canada, the CEPA is the key authority for the government to
require that new activities associated with chemicals manufactured or imported to Canada to be
assessed for their potential risks to the environment and human health. From time to time, the
DSL is amended to indicate the requirement to submit specific information to the government
prior to undertaking a "Significant New Activity" (SNAc) in relation to that substance. Under
TSCA, the U.S. issues "Significant New Use Rules" (SNURs) to require notification of
significant new uses of a substance and evaluates those notifications for potential unreasonable
risk to human health or the environment. The table below describes the key differences between
the two regulatory authorities.
4.2 Enabling Bilateral Communication
In Canada and the U.S., pre-notice consultations are primarily used by notifiers to consult
government officials during the planning or preparation of NSNs and PMNs to discuss any
questions or concerns they may have regarding notification procedures or regulatory
requirements. The North American Notification Consultation (NAN-C) process allows
companies wishing to notify simultaneously in both Canada and the U.S. the option of consulting
with both jurisdictions via a joint PNC.
Challenges to information-sharing during bilateral communication between jurisdictions involve
enabling discussions on EPA-defined Confidential Business Information (CBI) (e.g., masked
substance names, CAS RNs) and NSN/PMN assessment timelines. As part of the NAN-C
process, a bilateral limited disclosure agreement (BLDA) would be provided by the notifier to
enable sharing of CBI information. Use of the NAN-C process by notifiers interested in
initiation of NSNs or PMNs will enable timely communication on SNAcs and SNURs where
these are an outcome of the new substance review.
For more information about the NAN-C process in Canada please contact the Substances
Management Information Line: Toll-free in Canada, 1-800-567-1999; Outside Canada, 1-819-
938-3232; Fax, 1-819-938-5212; Email, ECCC.substances.ECCC@canada.ca.
In the U.S. please contact the Toxic Substances Control Act Hotline at 202-554-1404.
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Differences in US and Canadian Authorities for SNURs and SNAcs under TSCA and CEPA
Occupational safety and health
US: Assessments under TSCA can include
consideration of occupational exposures, and TSCA
provides authority for US EPA to establish new
chemical exposure limits (NCELs) among other
worker protection requirements.
Canada: Assessments under CEPA don't
include consideration of occupational
exposures. However, SNAcs may require
information to assess a substance and the
risks it may pose in a work environment.
Food and Drug Act uses
US: Uses of chemicals regulated under the US Food,
Drug and Cosmetic Act are exempt from TSCA
requirements,49 and SNURs cannot be applied to
these uses.
Canada: Substances used in products
regulated under Canada's Food & Drugs Act
are not exempt from CEPA, and SNAcs can be
applied to these substances in Canada.
New organisms
US: TSCA's authority in this area is limited, as only
certain genetically modified microorganisms can be
captured under the TSCA definition of "chemical
substance" and therefore subject to TSCA authority
(e.g., bacteria, fungi, algae, viruses, protozoa).
Canada: SNAcs can be issued for new
organisms under CEPA including more
complex genetically modified organisms.
Downstream notification requirements for new and existing substances
US: SNURs require information-sharing down the
supply chain regardless of whether they are new or
existing substances. Specifically, a person that
intends to manufacture, import, or process for
commercial purposes a chemical substance subject
to a SNUR, and intends to distribute that substance
in commerce, must either document that the
person has notified the recipient in writing of the
SNUR and the significant new use, document that
the recipient already has knowledge of the SNUR
and the significant new use, or document that the
recipient cannot undertake the significant new use.
Canada: Sections 86 and 111 of CEPA outline
requirements for substances not listed on the
DSL (new substances) and subject to SNAc
provisions; all recipients must be notified of
the obligation to comply with SNAc provisions.
For substances on the DSL (existing
substances) subject to a SNAc order, it is
recommended that this notification also be
carried out to allow recipients to be in a
position to determine their own SNAc
compliance obligations.
"Manufactured items" and "Articles"
US: Under TSCA, standard regulatory exemptions in
SNURs can be made inapplicable, e.g., the "article"
exemption can be made inapplicable to allow
articles containing substances of concern, including
those that are unintentionally released, to be
captured by SNUR requirements.
Canada: Currently, SNAc provisions in CEPA
do not apply to most substances contained in
manufactured items.
Substances in fluids and particles contained
within a manufactured item may be notifiable
if they are released during normal use in an
uncontrolled or dispersive manner.
Export notification
US: There are export notification requirements for
substances subject to SNURs.
Canada: There are no export notification
requirements for substances subject to SNAcs.
49 TSCA SNURs do not apply to pesticides; tobacco (or tobacco products); firearms and ammunition; source
material by-products or special nuclear material defined by the Atomic Energy Act; and food, food additives, drugs,
or cosmetics covered under the Federal Food, Drug and Cosmetic Act.
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U.S. Environmental Protection Agency Significant New Use Rule (SNUR) Programs and
Environment and Climate Change Canada / Health Canada Significant New Activity (SNAc) Provisions
5. Resources and Other Supporting Materials
EPA Resources
EPA website
https://www. eoa.gov/
EPA's ChemView
https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca/introduction-chemview
EPA's Substance Registry Services (SRS)
https://ofmpub.epa.gov/sor internet/registrv/subst
reg/searchandretrieve/substancesearch/search.do
SNUNs are reported using the standard e-PMN form and
are subject to a 90-day review process similar to that for
a PMN. Access to the e-PMN form
https://www.epa.gov/reviewing-new-chemicals-
under-toxic-substances-control-act-tsca/how-
submit-e-pmn
ECCC/HC Resources
SNAc Webpage
https://www.canada.ca/en/environment-climate-
change/services/canadian-environmental-protection-
act-registrv/signifi cant-new-activitv-provisions.html
Significant New Activity Publications under the
Canadian Environmental Protection Act, 1999 dataset
http://open. Canada. ca/data/en/dataset/bfab58
76-77e5-4dbf-8693-
3b0bc69428b8?wbdisable=false
Substances Search Tool (chemicals, polymers and
organisms)*
http://pollution-waste.canada.ca/substances-
search/Substance?Error=l&ld=1257085-86-
l&ExactMatch=False
Canada Gazette general website - where SNAc orders
and notices are published
http://www.gazette.gc.ca
Government of Canada RCC webpage
https://www.canada.ca/en/health-
canada/corporate/about-health-canada/legislation-
guidelines/acts-regulations/canada-united-states-
regulatory-cooperation-council.html
HC general website
https://www.canada.ca/en/health-canada.html
ECCC general website
https://www.canada.ca/en/environment-climate-
change.html
Substances Management Information Line
Toll-free in Canada: 1-800-567-1999
Outside Canada: 1-819-938-3232
Fax: 1-819-938-5212
Email: ECCC.substances.ECCC(®canada.ca
* The Substances search tool is a searchable database of substances previously published in the Canada Gazette
(e.g., substances on the DSL, NDSL, and new and existing substances subject to the SNAc provisions). Canada
Gazette publications are the official source for SNAc publications.
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U.S. Environmental Protection Agency Significant New Use Rule (SNUR) Programs and
Environment and Climate Change Canada / Health Canada Significant New Activity (SNAc) Provisions
5.1 Explanation of Key Terms
Canada Notice of Intent (NOI) - An NOI to amend the DSL is published in the Canada
Gazette, Part I (CG I), followed by a public comment period, and publication of an order
amending the DSL in the Canada Gazette, Part II (CG II). The SNAc provisions apply as soon as
the order is registered (i.e., in force) unless the order indicates otherwise.
Canada Significant New Activity (SNAc) - An activity conducted with a substance in a
different quantity, concentration, or in different circumstances that could affect the environment
or human exposure. What constitutes a significant new activity (or activities) is specific to each
substance and is found in the relevant SNAc publication in the Canada Gazette.
Canada Significant New Activity Notification (SNAN) - If a person's proposed activities with
a substance are captured by the definition of a significant new activity, that person is required to
submit a SNAN to the government for assessment within the specified regulatory time period
prior to the new activity being undertaken.
Canadian Environmental Protection Act, 1999 (CEPA) - An Act respecting pollution
prevention and the protection of the environment and human health in order to contribute to
sustainable development.
U.S. Premanufacture Notice (PMN) - Anyone who plans to manufacture (including import) a
new chemical substance for a non-exempt commercial purpose is required by TSCA to provide
EPA with notice before initiating the activity. A PMN must be submitted at least 90 days prior to
the manufacture of the new chemical or significant new use. An online version of the PMN form
is available on EPA's website in an electronic (e-PMN) format.
U.S. Significant New Use Notice (SNUN) - A manufacturer (including importer) or processor
intending to engage in a designated significant new use must submit a SNUN to EPA at least 90
days before manufacturing or processing the chemical for the significant new use. This
notification initiates EPA's evaluation of the chemical within the applicable review period.
Manufacture and processing for the significant new use is unable to commence until EPA has
conducted a review of the notice, made an appropriate determination on the notice, and taken
such actions as are required in association with that determination.
U.S. Significant New Use Rule (SNUR) -EPA issues regulations designating significant new
uses of a chemical so that Agency review occurs before chemical substances are used in new
ways that might create environmental and human health concerns. Once EPA designates a
significant new use for a chemical, manufacturers and processors of that chemical who wish to
initiate that use must submit a SNUN before manufacturing or processing the chemical for the
significant new use.
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U.S. Environmental Protection Agency Significant New Use Rule (SNUR) Programs and
Environment and Climate Change Canada / Health Canada Significant New Activity (SNAc) Provisions
U.S. Toxic Substances Control Act (TSCA) - Provides EPA with authority to establish
reporting, recordkeeping, testing requirements, and restrictions relating to chemical substances or
mixtures. TSCA addresses the production, importation, use, and disposal of specific chemicals.
Importer (TSCA) - Any person who imports a chemical substance, including a chemical
substance as part of a mixture or article, into the customs territory of the U.S. Importer includes
the person primarily liable for the payment of any duties on the merchandise, or an authorized
agent acting on his/her behalf.
Manufacturer (TSCA) - A person who imports, produces, or manufactures a chemical
substance.
Processor (TSCA) - Any person who processes a chemical substance or mixture. To process
means to prepare a chemical substance or mixture, after its manufacture, for distribution in
commerce in the same form or physical state as, or in a different form or physical state from, that
in which it was received by the person so preparing such substance or mixture, or as part of a
mixture or article containing the chemical substance or mixture.
5.2 ChemView Instructions
The EPA ChemView website https://chemview.epa.gov/chemview has links to a ChemView
User's Guide50 and Web Service Information. The User's Guide includes
• Selecting chemical search criteria
• Selecting outputs
• Generating results
• Viewing results
• Appendix of specific sources.
The Web Services URLs (uniform resource locators) site describes dropdowns for the user to
select the chemicals, SNUR uses, uses, groups, categories, and endpoints. The site also enables
the user to select different sources to get the chemical results. The default output format is
JavaScript Object Notation (JSON). ChemView also provides the ability to download to Excel,
XML, and PDF.51
50 ChemView Public UI [User Interface] Guide Release 1.3, U.S. Environmental Protection Agency, October 2015,
42 pages. Available at: https://chemview.epa.gov/chemview/resources/ChemView%20Public%20UI%20Guide.pdf.
51 ChemView Web Services URLs. Release 1.1, U.S. Environmental Protection Agency, February 19, 2014.
Available at https://chemview.epa.gov/chemview/resources/ChemView WebServices.pdf.
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oEPA Canada
April 2018
EPA 730-R-17-001
En14-320/2018E-PDF
978-0-660-25901-7
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