The presentation incorporates Topic of Biosafety on the Prospective of IPR.

1. An Assignment on
Bio-safety
By
Manoj Kumar

2. Table of Content
1. What is Biosafety
2. Biosafety Background and GMOs Concern
3. Risk Assessment
 Case Studies
4. Biosafety Guidelines
5. International Agreements
6. Biosafety Regulation in India

3. Biosafety
 Biosafety describes the principles, procedures and policies to be adopted to
ensure the environmental and personal safety.
 Biosafety refers to containment principles, technologies and practices that are
required to prevent unintentional exposure to pathogens and toxins, or their
accidental release into the environment [1].
 It is the prevention of large scale loss of biological integrity, focusing both
on ecology and human health [2].
 Bioethics and Biosafety
 Bioethics is the study of the typically controversial ethical issues emerging
from new situations and possibilities brought about by advances in biology and
medicine. It is also moral discernment as it relates to medical policy, practice, and
research.
 Biosafety is the prevention of large-scale loss of biological integrity, focusing
both on ecology and human health.

4.  Genetic engineering (GE) and genetically modified organisms (GMOs)
provide powerful tools for sustainable development in agriculture,
healthcare, environment and many other sectors [1].
 Sectors which uses GMOs are:
Agriculture (eg. GM Crops)
Healthcare (eg. Vaccines, Antibiotics)
Environment (eg. Bioremediation)
 GMOs are very useful in the research and development but if used
carelessly, it may have negative impacts on the environment and
human life [1].
 With the increasing emphasis on adoption of GE technique in different
countries in their life science research and development activities, the
biosafety issues are gaining importance to ensure safety of the
public and the environment [1].
Background

6.  Risks to Human Health[3]
1. Allergenicity : Transferred gene can also express allergic
proteins.
2. Toxicity: Production of toxic substances in the Gut and Antibiotic
resistance by Gut Bacteria after consumption of GM food.
 Risk to Environment[3]
Non Target Effect, Loss of Biodiversity, Superweeds, Antibiotic
resistance.
 Economic and Social concerns[3].
Increase in price because of the patenting of GM products and
Traditional and Religious concerns.
Risk Assessment

7.  A variety of GM Maize containing the Bacillus Thuringiensis (Bt) protein
Cry9C, made by Aventis Crop Science of the Research Triangle Park in
North Carolina, was found contaminating corn products in U.S. supermarkets
and restaurants.
 Starlink corn had only been approved for animal feed as the Cry9C protein
lasts longer in the digestive system than other Bt proteins raising concerns
about its potential allergenicity.
 In 2000, Taco Bell-branded taco shells sold in supermarkets were found
to contain Starlink, resulting in a recall of those products, and eventually led
to the recall of over 300 products.
 Sales of Starlink seed were discontinued and the registration for the
Starlink varieties was voluntarily withdrawn by Aventis in October 2000.
 Aid sent by the United Nations and the United States to Central African nations
was also found to be contaminated with Starlink corn and the aid was rejected.
 The U.S. corn supply has been monitored for Starlink Bt proteins since 2001
and no positive samples have been found since 2004.
 Case Study: Starlink Maize[4].

9.  Case Study: Monsanto vs Schmeiser Case[4].
 In 1997, Percy Schmeiser, a canola breeder and grower in Bruno,
Saskatchewan, discovered that one of his fields had canola that was
resistant to Roundup.
 He had not purchased this seed, which had blown onto his land from
neighboring fields. He later harvested the area and saved the crop in the
back of a pickup truck.
 Before the 1998 planting, Monsanto representatives informed Schmeiser
that using this crop for seed would infringe the patent, and offered him a
license, which Schmeiser refused.
 According to the Canadian Supreme Court, after this conversation
"Schmeiser nevertheless took the harvest he had saved to a seed
treatment plant and had it treated for use as seed.”
 "After further negotiations between Schmeiser and Monsanto broke down,
Monsanto sued Schmeiser for patent infringement and prevailed in the
initial case.
 Schmeiser appealed and lost. Canadian Supreme Court, which in 2004
ruled 5 to 4 in Monsanto's favor, stating that "it is clear on the findings
judge that the appellants saved, planted, harvested and sold the crop from
plants containing the gene and plant cell patented by Monsanto".

10.  Biosafety Guidelines are the policies proposed or adopted by the
government (National or International) to avoid the risk of GMOs on
public health and environment[5].
 Aim of Biosafety Guidelines [5]
 Regulating R-DNA research with organism that have least or no
adverse effect on health and environment.
 Minimizing the possibility of occasional release of GMOs from the
Laboratory.
 Banning the release of GMOs if they are supposed to be causing any
risk in health and environment.
Biosafety Guidelines

11.  Convention on Biological Diversity (CBD) 1992 [5]
 scope of the Convention and its objectives are
 the conservation of biological diversity
 the sustainable use of its components
 the fair and equitable sharing of the benefits arising out of the
utilization of genetic resources.
 Main Focus of CBD is the management of risks associated with
living modified organisms (LMO’s) resulting from Recombinant
DNA technology.
International Agreements

12.  The Codex Alimentarius Commission [6]
 In 1962, the Codex Alimentarius Commission (Codex Alimentarius or Codex)
was formed under the joint sponsorship of two United Nations (UN)
organizations: the World Health Organization (WHO) and the Food and
Agriculture Organization (FAO).
 It Included Guideline for the Conduct of Food Safety Assessment of Foods
Derived from Recombinant-DNA Plants is careful to state that “the concept of
substantial equivalence is a key step in the safety assessment process
(2003).
 Although, it is not a safety assessment in itself; rather it represents the
starting point which is used to structure the safety assessment of a new food
relative to its conventional counterpart”.
 The guideline also makes clear that a safety assessment of a new food based on
the concept of substantial equivalence “does not imply absolute safety of the
new product; rather, it focuses on assessing the safety of any identified
differences so that the safety of the new product can be considered relative
to its conventional counterpart”.

13.  ICGAB (The International Centre for Genetic Engineering and
Biotechnology) [7]
 It was established as a project of the united nations industrial
development organization (UNIDO) in 1983.
 In February 1994, ICGAB Became the International organization
and now has over 65 member States across the world.
 The ICGEB has also played an important role in issue related to
biosafety and the environmentally sustainable use of
biotechnology.
 The ICGEB organizes annual workshops on biosafety and on risk
assessment for the release of GMOs.
 Since September 1998, the ICGEB has provided an on-line
bibliographic data-base on biosafety and risk assessment for the
environmental release of GMOs.
 The ICGEB is also assisting to its Member States in developing the
national biosafety framework.

14.  Cartagena Protocol on Biosafety to the Convention on Biological
Diversity 2000 [5] [8]
 The Protocol is was adopted in 2000 and entered into force by
September, 2003. It is the first global legally binding instrument
focusing on LMOs.
 The purpose of the Protocol is to ensure adequate levels of protection
in the field of safe transfer, handling and use of LMOs resulting from
modern Biotechnology.
 The Protocol is applicable to all LMOs apart from those that are
pharmaceuticals for humans that are addressed by other international
agreements.
 It established an Advance Informed Agreement (AIA) which requires,
prior to the first intentional introduction into the environment of an
importing party.
• a notification the party of export containing certain information
• the acknowledgement of its receipt
• the written consent of the party of import.

15.  India has accepted to the biosafety protocol on 17th January 2003.
GMOs are regulated under the preview of the 1986 Environment
(protection) Act .
 The ministry of Environment and forests (MOEF) promulgated in
December, 1989 the rules and procedures for the manufacture,
import, use, research, and release of GMOs as well as products made
from such organisms; this is done under the provisions of the
Environment Protection Act, 1986 (EPA).
 Any violation and noncompliance, including non reporting of activities,
in this area would attract the punitive actions provided under the EPA.
 The Indian Recombinant DNA safety guidelines and Regulations,
1990 have been prepared by and available from request from
Recombinant DNA Advisory Committee (RDAC), Department of
Biotechnology (DBT), New Delhi [2] [9].
Regulation in India

16.  The Recombinant DNA safety guidelines are being implemented through
the following mechanisms [9]:
I. Recombinant DNA Advisory Committee (RDAC)
- take note of developments at national and international levels in
Biotechnology towards the currentness of the safety regulation for India on
recombinant research use and applications.
II Institutional Biosafety Committee (IBSC)
- monitors the research activity at institutional level.
III Review Committee on Genetic Manipulation (RCGM)
- in the DBT which allows the risky research activities in the laboratories.
IV Genetic Engineering Approval Committee (GEAC)
- the Ministry of Environment and Forest has the power to permit large scale
use of GMOs at commercial level, and open field trials of transgenic
materials including agricultural crops, industrial products, health care
products, etc.
CONT:

17.  Operation of Biosafety Guidelines and Regulations in India
 All the institutions/industries working on genetic engineering activities
have IBSCs.
 with the permission of RCGM research activities are being carried out in
the country using transgenic materials.
 Some of the examples are [2]:
 M/S Proagro PGS India Ltd had imported the transgenic mustard seeds
expressing Barstar and Barnase genes from Belgium to evaluate the
performance of seeds in Indian soils. This company has also imported
transgenic seeds of tomato containing B. thuringiensis (Bt) CRYIA(b) gene to
assess the resistance of cultivars containing transformed potato plants with the
above gene to specific tomato fruitworms of India.


18.  Examples
 M/S MAHYCO, Mumbai imported seeds of transgenic cotton containing
Bt gene to conduct trials in glasshouse by back crossing with Indian cotton
lines and to evaluate resistance of the transgenic plants to boll worms in
India.
 M/S Transgene Vaccines Ltd, Hyderabad imported the recombinant strains
of yeast expressing Hepatitis B surface antigen protein. The company was
granted permission to carry out experiments for small scale production of
vaccines at IMTECH, Chandigarh.
 M/S Santha 3iotechnics Ltd, Hyderabad conducted experiments for the
production of recombinant Hepatitis B vaccines and human a-interferon by
using yeast and E.coli respectively.

19. 1. Kumar, S. (2014). Biosafety issues of genetically modified
organisms. Biosafety, 3, e150.
2. https://biocyclopedia.com/index/biotech_biosafety_ipr_ipp.php
3. Terefe, M. (2018). Biosafety issues of genetically modified crops:
Addressing the potential risks and the status of GMO crops in
Ethiopia. Clon Transgen, 7(164), 2.
4. Bucchini, L., & Goldman, L. R. (2002). Starlink corn: a risk
analysis. Environmental health perspectives, 110(1), 5-13.
5. Alexandrova, N., Georgieva, K., & Atanassov, A. (2005). Biosafety
regulations of GMOs: national and international aspects and regional
cooperation. Biotechnology & Biotechnological Equipment, 19(sup3), 153-
172.
6. Kimbrell, E. (2000). What is Codex Alimentarius?.
7. https://www.icgeb.org/about-us/who-we-are/
8. https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf
9. http://www.iitk.ac.in/bsbe/committee/Annex-5.doc
References