8-Hour Training Course
MODULE 6: REGULATIONS AND
STANDARDS RELEVANT TO
NANOMATERIAL WORKPLACES
INTRODUCTION TO NANOMATERIALS AND
OCCUPATIONAL HEALTH
Eight-Hour Training Course
Module 1 Introduction to Nanotechnology and Nanomaterials
Module 2
What Workers Need to Know about Nanomaterial
Toxicology and Environmental Impacts
Module 3 Assessing Exposure to Nanomaterials in the Workplace
Module 4 Controlling Exposure to Nanomaterials
LUNCH
Module 5
Risk Management Approaches for Nanomaterial
Workplaces
Module 6
Regulations and Standards Relevant to Nanomaterial
Workplaces
Module 7 Tools and Resources for Further Study
6-2
Lesson Overview
Purpose
To provide workers with introductory
information about standards and regulations
relevant for nanomaterial workplaces
Topics
1. US regulatory activity in nanotechnology
2. Canadian regulatory activity in nanotechnology
3. Standards developed for nanomaterial handling
6-3
Learning Objectives
At the end of this module you should be able to
 Summarize major developments in
nanotechnology regulation in the US and
Canada
 Articulate other standards that are applicable
to nanomaterial workplaces
6-4
Recent Regulatory Actions by Sector
Foods/
Ag
European
Commission
C
Chemistry &
Materials
Cosmetics
A
A
France
B
B
C
Medicinal
products &
medical
devices
Occupational
issues
(OSH)
Environment
Cross sectoral
(nanomaterials,
nanotech in
general)
A
A
A
C
A
A
A
B
Germany
A
A
A
The
Netherlands
A
A
A
Switzerland
A
A
United
Kingdom
A
USA
A
A
A
A
B
A
A
A
Canada
A
B
A
A
Australia
A
B
Japan
C
A
Other
Countries
A
A
A
A
A
A
B
A
A
C
A
A
C
A
A
A
A
A. Provide guidance to support safety assessment.
B. Adapt/strengthen premarket notification procedures.
C. Introduce amendments and changes to existing legislation.
http://www.observatorynano.eu/project/filesystem/files/ObservatoryNano_Nanotechnologies_RegulationAndStandards_2012.pdf
6-5
Topic 1
US REGULATORY ACTIVITY IN
NANOTECHNOLOGY
Most Relevant US Government
Agencies
Regulatory
Environment
Fund or Perform Risk Research
Food & Drugs
Worker Safety
Consumer
Products
Food
6-7
History of OSHA
OSHA stands for the Occupational
Safety and Health Administration,
an agency of the U.S. Department
of Labor
 OSHA’s responsibility is worker
safety and health protection



On December 29, 1970, President Nixon signed the OSH
Act
This Act created OSHA, the agency, which formally came
into being on April 28, 1971
6-8
Applicable OSHA Standards
Occupational Safety and Health Act of 1970 (29
U.S.C. 654)
 General Duty Clause Section 5(a)(1) requires
employers to “furnish to each of his employees
employment and a place of employment which
are free from recognized hazards that are causing
or are likely to cause death or serious physical
harm to his employees.”
 Section 5(a)(2) requires employers to "comply
with occupational safety and health standards"
promulgated under this Act.
6-9
What Rights Does a Worker Have Under
OSHA?
A worker has the right to:
◦
◦
◦
◦
◦
◦
◦
◦
◦
A safe and healthful workplace
Know about hazardous chemicals
Information about injuries and illnesses in your workplace
Complain or request hazard correction from employer
Training
Hazard exposure and medical records
File a complaint with OSHA
Participate in an OSHA inspection
Be free from retaliation for exercising safety and health rights
6-10
The Right to Know about Hazardous
Chemicals
Employers must have a written, complete hazard
communication program that includes
information on:



Container labeling,
Material Safety Data Sheets (MSDSs), and
Worker training.
The training must include the physical and health
hazards of the chemicals and how workers can
protect themselves; including specific
procedures the employer has implemented to
protect workers, such as work practices,
emergency procedures, and personal protective
equipment.
Very similar to requirements of the Workplace Hazardous Materials Information System (WHMIS)
6-11
OSHA-Identified Nanomaterial Stds









1904, Recording and reporting occupational injuries and
illness
1910.132, Personal protective equipment, general
requirement
1910.133, Eye and face protection
1910.134, Respiratory protection
1910.138, Hand protection
1910.141, Sanitation
1910.1200, Hazard communication
1910.1450, Occupational exposure to hazardous chemicals
in laboratories
Certain substance-specific standards (e.g., 1910.1027,
Cadmium)
6-12
Environmental Protection Agency
Statute
Acronym
Topic
Toxic Substances Control Act
TSCA
chemical substances
Federal Insecticide, Fungicide, and
Rodenticide Act
FIFRA
pesticides
Clean Air Act
CAA
air pollutants
Clean Water Act
CWA
discharge of pollutants
into the navigable waters
Comprehensive Environmental Response,
Compensation and Liability Act
CERCLA
uncontrolled releases of
hazardous materials
Resource Conservation and Recovery Act
RCRA
solid or hazardous waste
6-13
Some Branches on TSCA Decision Tree
Is it a chemical substance; i.e., does it have a
particular molecular identity?
Is it already listed on the TSCA inventory in a
non-nanoscale form?
Is it exempt because it is an intermediate,
impurity, or produced in very low volume?
6-14
Substances EPA Recognizes as Distinct
Feature
Molecular formula
Example
C2H6
EPA Verdict
C3H8
DIFFERENT
Isomers
DIFFERENT
Crystal Structures
DIFFERENT
Allotropes
DIFFERENT
6-15
Substances Defined to be the Same
Featu re
Exam p le
EP A V e rd ict
A ggregates o r p a rticles o f
kn o w n su b stan ces
SA M E
N an o scale ve rsio n s o f
kn o w n su b stan ces
SA M E
“Although a nanoscale substance … differs in particle size and may differ in
certain physical and/or chemical properties, EPA considers the two forms to
be the same chemical substance because they have the same molecular
identity.”
What It Is
What It Does
6-16
Low-Volume Exemption (LVE)
Is it exempt because it is an intermediate,
impurity, or produced in very low volume?
Many nanoscale substances could qualify for an
exemption from TSCA reporting and testing
requirements if less than 10,000 kg/yr are sold.
6-17
Recent Actions taken by EPA (2010)
Designates any use of nanoscale substance as a
Significant New Use, which would require 90-day
pre-commerce notification (PROPOSED)
2. Requires companies to report production volume,
methods of manufacture and processing, exposure
and release information, and available health and
safety data (PROPOSED)
3. Requires manufacturers to conduct testing for
health effects, ecological effects, and environmental
fate, as well as to provide material characterization
data on certain multiwall carbon nanotubes, and
nanoscale clays and alumina (PROPOSED)
1.
6-18
Requirements EPA Has Imposed

For certain multiwall carbon nanotubes
◦ Use gloves impervious to nanoscale particles and
chemical protective clothing;
◦ Use a NIOSH–approved full-face respirator with an N 100 cartridge while exposed by inhalation in the work
area
◦ Distribute the … substance only to a person who
agrees to follow the same restrictions

Siloxane modified silica nanoparticles
◦ use with impervious gloves or a NIOSH-approved
respirator with an APF of at least 10
6-19
Topic 3
CANADIAN REGULATORY
ACTIVITY
Government of Canada on Nano c.2003

Nanotechnology in Canada presents deficiencies
◦ Absence of a well defined strategy
◦ Poor coordination of research efforts
◦ Insufficient training
More research is warranted into the health and environmental
effects of nanotechnology
 There is a need to rethink environmental assessments
 Certain nanoparticles may have detrimental effects on health

◦ Pulmonary toxicity that is related to surface area
◦ Entry into blood circulation facilitated by small size
Public perception will become a problem. Public policy and media
strategy must be designed to manage this.
 There is a need to close the gaps between

◦ Ethics and science
◦ Industrialized and developing countries
6-21
Relevant Canadian Statutes and
Regulations





Canada Labor Code (R.S., 1985, c. L-2)—Occupational
Safety
Canada Occupational Health and Safety Regulations
(SOR/86-304), especially parts X (hazardous substances), XI
(confined spaces), XII (safety materials, equipment, devices,
and clothing), and XIV (materials handling)
Canadian Environmental Protection Act (1999, c. 33),
especially parts 4 (pollution prevention), 5 (controlling toxic
substances), 6 (animate products of biotechnology), and 7
(controlling pollution and managing wastes)
Hazardous Products Act (R.S., 1985, c. H-3) and the
Controlled Products Regulations (SOR/88-66), where such
products have nanoscale components
Food and Drugs Act (R.S., 1985, c. F-27 )
6-22
Proposed Approach for a Regulatory
Framework for Nanomaterials (2007)
Environment Canada and Health Canada propose
 Phase 1 (started fall 2006)
◦ Continue work with international partners to develop scientific and research
capacities (OECD, ISO).
◦ Inform potential notifiers of their regulatory responsibilities under the current
framework.
◦ Develop initiatives to gather information from industry on the uses, properties,
and effects of nanomaterials.
◦ Consider whether amendments to CEPA 1999 or the NSNR would be needed
to facilitate the risk assessment and management of nanomaterials.

Phase 2 (starting 2008)
◦ Resolution of terminology and nomenclature by ISO TC229.
◦ Consider establishing data requirements under the NSNR specific to
nanomaterials.
◦ Consider the use of the Significant New Activity (SNAc) provision
of CEPA 1999 to require notification of nanoscale forms of substances already
on the DSL.
http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=FD117B60-1
6-23
Nanomaterials Under the Canadian Environmental
Protection Act, 1999 (CEPA)
CEPA: pollution prevention and protection of
environment and human health
 Part 5 deals with assessment and management of
new and existing commercial and industrial
substances
 New Substances Notification Regulations
(Chemicals and Polymers): Premarket notification
to Environment Canada and Health Canada
 “New” means anything not already on the
Domestic Substances List (DSL)
 Nano is new if it has “unique structures or
molecular arrangements”
6-24
New Substances Program Advisory
Note (2007-06)
‘The nanoscale form of a substance on the DSL is
considered a “new” substance if it has unique
structures or molecular arrangements.’
C60
NEW
Nano-TiO2
NOT NEW
6-25
Workplace Hazardous Materials
Information System (WHMIS)
Canada’s hazard communication standard.
Key elements:
 Derives from Hazardous Products Act
(administered by Health Canada) and Controlled
Products Regulations
 Implemented through federal, provincial, and
territorial legislation
Employers must:
 ensure that controlled products used, stored,
handled, or disposed of in the workplace are
properly labeled
 MSDSs are made available to workers
 and workers receive education and training to
ensure the safe storage, handling, and use of
controlled products in the workplace
6-26
Topic 3
STANDARDS DEVELOPED FOR
NANOMATERIAL HANDLING
Voluntary Consensus Standards
Standard Developing Organizations produce
standards according to a voluntary consensus
process.
 The standards are not binding but can be
incorporated into regulations or codes.
 The standards process can serve as a stop-gap
attempt at self-regulation in fast-moving or
emerging areas where regulation is not set.

6-28
Other Standards: ISO and ASTM

ASTM E2535-2007: Standard Guide for Handling
Unbound Engineered Nanoparticles in
Occupational Settings
◦ Practical guidance for reducing unwanted exposure to
nanomaterials that could pose an inhalation hazard

ISO/TR 12885:2008 Nanotechnologies—Health
and safety practices in occupational settings
relevant to nanotechnologies
◦ Review of state of knowledge with general guidance for
occupational practice
6-29
2012: Canada is Deeply Engaged in
International Nano Governance Bodies
ISO/TC 229 Nanotechnologies:VOLUNTARY STANDARDS
• Developing consensus standards for terminology, characterization, and health &
safety
• Technical Report on health & safety practices in occupational settings
• Multi-stakeholder: government, industry, legal, academic, non-governmental
• Canada is convenor of Working Group 1 on Terminology and Nomenclature
Organization for Economic Cooperation and Development
INTERGOVERNMENTAL GROUP
• Safety testing on representative set of nanomaterials; development of test
guidelines for assessing nanomaterial toxicity
• Primarily government officials
• Canada chairs Steering Group 5 on Co-operation on voluntary schemes and
regulatory programmes
6-30
Learning Objectives
At the end of this module you should be able to
 Summarize major developments in
nanotechnology regulation in the US and
Canada
 Articulate other standards that are applicable
to nanomaterial workplaces
6-31
Eight-Hour Training Course
Module 1 Introduction to Nanotechnology and Nanomaterials
Module 2
What Workers Need to Know about Nanomaterial
Toxicology and Environmental Impacts
Module 3 Assessing Exposure to Nanomaterials in the Workplace
Module 4 Controlling Exposure to Nanomaterials
LUNCH
Module 5
Risk Management Approaches for Nanomaterial
Workplaces
Module 6
Regulations and Standards Relevant to Nanomaterial
Workplaces
Module 7 Tools and Resources for Further Study
6-32