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

12

• 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

13

• 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

14

• 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

15

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)

16

• 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

17

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

18

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

19

-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

20

-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 :

22

• 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