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Nanotechnology safety and risk governance in the Islamic Republic of Iran
Mahmoud Ghazi-Khansari; PhD
Department of Pharmacology, School of Medicine, Tehran University of Medical Sciences Tehran, IR Iran
• INSN
• Iran Nano Health
Committee
• Nanotechnology Committee
of Jihad-E- Agriculture
Mission Networking researchers, experts, research institutes and
industrial unites which are active in the field of EHS Determining national priorities in direction with mission
of nanosafety network and performing these priorities with cooperation of other related national organization and centers
Writing national and international standards, Guidelines and Regulation in the filed of nano EHS
Providing the necessary hardware and software infrastructures
INSN structure
Iran Nanotechnology Initiative Council
INSN
Chairman of INSN
secretariat
Steering committee
Human Health Safety WG1
Occupational safety WG2
Environmental Safety WG3
Nanoethics WG4
Steering committee Steering committee including 7 people who are representatives
from INIC, Ministry of Health, Ministry of Agriculture, National standard organization and universities
Main tasks: Compiling strategic program and making policies for INSN
Legislating internal regulations
Supervising in WGs activities
Approving the proposed projects of WGs
• Human Health Safety WG including 12 people who are experts, university professors and representatives from ministry of Health
• Occupational safety WG including 7 people from universities and research institutes who are experts in occupational health
• Environment Safety WG including 12 people who are representative from environment organization, ministry of Agriculture and experts from universities and research institutes in the filed of environmental aspect of nanotechnology
• Nanoethics WG including 5 people who are experts in ethics and law and socio economic aspect on emerging technology
Human Health Safety WG priorities and main programs
Scope of this WG including: safety and health of nanoproducts in the field of foods, cosmetic, drugs, healthcare , medical devices and instruments.
Main programs:
In vivo and in vitro studies on the effects of nanomaterials in human and body response to these materials
Characterization and measurement of nanomaterials in biological media
Studying of relation between physico-chemical properties of nanomaterials and some factors such as absorption, metabolism, distribution and excretion in human body
Studying of relation between physico-chemical properties of nanomaterials and diffusion of naomaterials to tissue and organs in the human body
How the human body responses to nanomaterials in molecular scale
Studying effect of nanomaterials on human health in different life stages
Occupational safety priorities and programs
Scope of this WG including: Human resources training, compiling
standards and providing infrastructures in the field of occupational
safety for laboratories and companies which are active in
nanotechnology
Main program :
• Assessing process and factors which affect in amount of exposure
• Identifying groups who can be exposed to nanomaterials
• Studying the effects of exposure with different of nanomaterials
• Surveying risk and hazard evaluation, exposure assessment and
designing new model and methods for risk assessment of
nanomaterials
• Identifying and control amount of exposure with nanomaterials in
different groups and media
Environmental Safety WG priorities and programs:
Scope of this WG including: compiling standards, regulation and guidelines for environment and agriculture in the filed of nanotechnilogy
Main programs:
Life cycle analysis of nanomaterials
Fate of nanmoaterials in environment
Determining the factors which affect in transfer of nanomaterial to environment
Study of different environmental condition in transfer manner of nanomaterials
Risk management and presenting new working framework
Effects of nanomaterials on ecosystems
Nanoethics WG priorities and programs
Scope of this WG including: legitimating regulation and law, social acceptance of nanotechnology and ethics
INSN activities
Studying of national and international activities in the field of nanosafety, and other similar network
Different activities in training and holding workshop and congress Holding first national seminar” safety and standardization in nanotechnology on
June 2012
Holding safety of nanomaterial in human health and environment
3 workshops “safety of nano agriculture products “
Holding workshops “Health and safety practices in nano laboratories” 2013
10 Keynote and Invited speakers
Workshop Advances in nanomedicine R & D
Mission of the Iran Nano Health Committee
www.nanohealth.ir
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• Nanotechnology Committee of Food and Drug Organization has been formed to develop guidelines to assess and approve Nano-Health products of Iran's Market in the areas of pharmaceuticals, medical equipment, cosmetics and hygienic, food, beverages and pharmaceutical supplements.
• This committee has focused to identify measurement, handling, exposure, efficacy, toxicity, and safety standards of Nanohealth products by establishing the national responsible Iran Nanohealth committee .
Committee members
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• Committee members include committee chairman and secretary in general, director of different departments in the Food and Drug Organization (FDO) and assignee of Iran Nanotechnology Initiative Council (INIC).
• Iran Nanohealth Committee Secretariat follows the Committee duties and administrative affairs under the supervision of Secretary in general of the committee.
• Secretariat experts are responsible to register Nanohealth products and categorize the raw materials and finished products in related groups, assess their documents and finally to present them in respective Professional Working Groups (PWG).
Professional Working Groups
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• Professional Working Groups formed to provide consulting services, particularly developing criteria and guidelines which are required for assessing Nano-Health products.
• These Groups consist of experts and academic members who are specialized in related fields and also executive experts of Food and Drug Organization’s departments and Health Ministry. At present, four active working groups have been established including:
• 1) Pharmaceuticals PWG • 2) Medical Essentials and equipments PWG • 3) Cosmetic – hygienic PWG • 4) Food and beverage PWG
Committee activities
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1 -Developing guidelines and administrative instructions relating to assess and approve Nano-Health products .
2 - Assessing and making decisions about the registered products.
3 -Educating experts of the Food and Drug Organization, Ministry of Health, the applicant companies, academic volunteers etc.
4 -Professional Promotion and interaction with manufacturers in the related areas
5 - Supporting the commercialization of Nano-Health products
Professional product bases Check Lists
(available at http://nanohealth.ir)
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• Nanotechnology based Cosmetics & Hygienic raw materials
• Nanotechnology based Cosmetics & Hygienic products
• Nanotechnology based Medical Essentials and equipments raw materials
• Nanotechnology based Medical Essentials and equipments products
• Nanotechnology based food packaging
• Nanotechnology based food additives
• Nanotechnology based supplements raw materials
• Nanotechnology based supplements product
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Health Concerns
according to
international guidelines
ENM s Indications
Performed according to
the FDA guideline Nanoliposomal
Doxorubicin
Cancer
Therapy
Performed according to
the FDA guideline
Nanoliposomal
Amphotericin B
Fungal
infections,
Leishmaniasis
Performed according to
the FDA guideline
Nanocurcumin Cancer
Prevention
Nanodrugs and Supplements in Iran
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Nano-Health registered products in Iran market (N=180 from 60 companies)
Required Safety tests Active agent Application
Product
category
-Skin irritation Colloidal nanosilver -Topical solution
-Topical foam
Antiseptics
-Skin irritation
-Mutagenicity
-Cytotoxicity
-Accumulations in related
tissues
Colloidal nanosilver -Wounds solution
- Burn wounds solution
- Prep solution
-Vaginal foam
-Injection zone solution
-Foot & shoe spray
-Acute inhalation toxicity
-Mutagenicity
-Skin irritation
- Oral LD50
Colloidal nanosilver - Hospital devices &
instruments solution
- Hospital floor and surfaces
solution
-Washing machine
antibacterial solution
- Air spray
Disinfectants
-Release test
-Skin irritation
Silver nanoparticles -Antibacterial polyester string
- Antibacterial textiles Textiles
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-Release test
-Skin irritation
Nanosilver/
nanotitanium /
nanozinc oxide
-Antibacterial tiles &
ceramics
-Antibacterial color
-Antibacterial flooring
-Antibacterial coating
spray (imported)
-Antibacterial epoxy
Tile,
Ceramics,
coatings &
Colors for
hospitals and
laboratories -Release test
-Skin irritation
Nanosilica -Decorative crack colors
-Crack nail polish
-Skin irritation
-Mutagenicity
-Cytotoxicity
-Accumulations in
related tissues
Colloidal
nanosilver/crystalline
nanosilver
-Antimicrobial pads for
injection zone
-Antimicrobial gauze
-Burn wound dressing
(imported)
-Wound dressing
Dressings
Nano-Health products in Iran market
Required Safety tests Active agent Application
Product
category
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-Acute inhalation toxicity nanofiber -Masks & filters
Masks & Filters -Acute inhalation toxicity
-Release test
-Skin irritation
Nanosilver particles -Antibacterial masks
-Acute oral toxicity
-Acute dermal toxicity
-Acute dermal irritation
-Acute eye irritation
-Acute skin sensitization
-Human repeated insult
patch
-Acute dermal photo
irritation
-Photosensitization
-In vitro
Mutagenicity
-Photo toxicity
-Ames test
-Micronucleus test
- Photomutagenicity
-Chromosome aberration
test
Nanotitanium dioxide -Raw material for sunscreens
(imported)
Sunscreens
- Acute inhalation toxicity
-Skin irritation
nanodendrimer -Aromatic nanoparticles for
textiles Odors
- Acute inhalation toxicity
-Skin irritation
Nano capsulated odor -Insecticides
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- Acute oral toxicity
- Mouth mucous irritation
- Mouth mucous
cytotoxicity
Colloidal nanosilver -Antimicrobial
mouthwash Toothpastes
& mouth
solutions
-Release test
-Skin irritation
nanosilver -Antibacterial tissues
-Antibacterial diapers
-laddies pad Tissues
-Skin irritation
-Related ecotoxicity
-Zero valence
nanoferrous
-Machine wash powder
Detergent &
Cleaners
-Acute inhalation toxicity
-Acute oral toxicity
-nanosilica -Raw material for glass
cleaner (imported)
-Acute inhalation toxicity -nanosilica -Surface cleaner spray
Acute inhalation toxicity -nano titanium dioxide/
nanosilica
-Waterproof & anti stain
spray
Acute inhalation toxicity nanosilicon polymer -Anti fog spray
Effectiveness & Challenges :
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• Nanotechnology studies have an increasing impact on scientific production in Iran and this support encouraged many companies to invest on the production or importation of Nanotechnology based health products and raw materials without concerning their safety issues or additional benefits to similar non nano products .
• According to the committee efforts more than two third of Nanohealth products have been covered by the expert committee from 2010 to present but some companies are still producing nonchemical without obtaining registration from the committee because they don’t claim about that .
• Risk of falsification of documents and chemical material data during random inspections is another major challenge .
33518 ت/18218 شماره تصويبنامه استناد به•
در وزيران محترم هيات 10/5/1384 مورخ ه
نانو فناوري توسعه راهبردي سند ابالغ خصوص
هر و اجتناب ستاد در كاري تمركز از گرديد مقرر
به خود اصلي ماموريت حوزه در دستگاهي
.بپردازد نانو فناوري
ستاد عضو دستگاههاي همه منظور همين به•
عنوان با تخصصي اي كميته تشكيل به موظف .گرديدند نانو فناوري كميته
Nanotechnology Committee of Jihad-E-
Agriculture
Committee Activities
Areas
Applied Project
Development
Human Resource
Development, Education and
Promotion
Infrastructure Development Standard
Commercialization
-Strategizing Nanotechnology in Agriculture and
Natural Resources
-Establishment of the Standard and Training sub-Committees.
-The Number of Approved and Supported Research Projects: 52.
Develop Guidelines for Evaluating NanoAgriculture Products
(Nanosilver Carrier Disinfectants, Packaging Products, Fruit Nanowaxes, and
Nanofertilizers).
- The Number of Introductory, Graduate and Professional-level
Courses, : Up to 60
Nanotechnology Committee of Jihad-E- Agriculture
Number of companies Areas
5 Nanofertilizer
13 Packaging
1 Fruit Nanowaxes
4 Agricultural Super
Absorbent
3 Wood Industrial
3 Food
1 Nano Device Several companies (As disinfectant in
Production Units, especially in Poultry
and Fisheries)
Nanosilver-based
Disinfectant
List of Private Companies Involved in Nanotech Field of Agriculture
Thank you